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Trial record 1 of 1 for:    NCT02793232
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Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979.

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ClinicalTrials.gov Identifier: NCT02793232
Recruitment Status : Completed
First Posted : June 8, 2016
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy Subjects
Interventions Drug: PF-06751979 single dose
Drug: Placebo single dose
Drug: PF-06751979 multiple ascending dose
Drug: Placebo multiple ascending dose
Drug: PF-06751979 multiple dose
Drug: Placebo multiple elderly dose
Enrollment 46
Recruitment Details  
Pre-assignment Details Study was conducted in 3 parts: Part A (4-period cross-over design), Part B and C (single period, parallel design).
Arm/Group Title Part A- Placebo, PF-06751979: 400 mg, 540 mg, 200 mg Fed Part A-PF-06751979 200mg,Placebo,PF-06751979 540 mg,200 mg Fed Part A-PF-06751979: 200mg, 400mg,Placebo,PF-06751979 200mg Fed Part A- PF-06751979: 200 mg, 400 mg, 540 mg, Placebo Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description Participants received oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 milligram (mg) suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days. Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days. Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days. Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state. After completion of period 4, participants were followed for 10 days. Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Period Title: Period 1-Part A:5 Days; Part B,C:19 Days
Started 2 2 2 2 7 12 9 2 8
Completed 2 2 2 2 6 12 8 2 8
Not Completed 0 0 0 0 1 0 1 0 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0             1             0             0
Period Title: Washout Period 1(Part A:at Least 10days)
Started 2 2 2 2 0 0 0 0 0
Completed 2 2 2 2 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Period 2 (Part A: 5 Days)
Started 2 2 2 2 0 0 0 0 0
Completed 2 2 2 2 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Washout Period 2(Part A:at Least 10days)
Started 2 2 2 2 0 0 0 0 0
Completed 2 2 2 2 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Period 3 (Part A: 5 Days)
Started 2 2 2 2 0 0 0 0 0
Completed 2 2 2 2 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Washout Period 3(Part A:at Least 10days)
Started 2 2 2 2 0 0 0 0 0
Completed 2 2 2 2 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Period 4 (Part A: 5 Days)
Started 2 2 2 2 0 0 0 0 0
Completed 2 2 2 2 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0
Arm/Group Title Part A- Placebo, PF-06751979: 400 mg, 540 mg, 200 mg Fed Part A-PF-06751979 200mg,Placebo,PF-06751979 540 mg,200 mg Fed Part A-PF-06751979: 200mg, 400mg,Placebo,PF-06751979 200mg Fed Part A- PF-06751979: 200 mg, 400 mg, 540 mg, Placebo Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg Total
Hide Arm/Group Description Participants received oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 milligram (mg) suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days. Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days. Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days. Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state. After completion of period 4, participants were followed for 10 days. Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Total of all reporting groups
Overall Number of Baseline Participants 2 2 2 2 7 12 9 2 8 46
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 12 participants 9 participants 2 participants 8 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
2
 100.0%
2
 100.0%
7
 100.0%
12
 100.0%
9
 100.0%
0
   0.0%
2
  25.0%
38
  82.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
 100.0%
6
  75.0%
8
  17.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 2 participants 7 participants 12 participants 9 participants 2 participants 8 participants 46 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
3
  37.5%
4
   8.7%
Male
2
 100.0%
2
 100.0%
2
 100.0%
2
 100.0%
7
 100.0%
12
 100.0%
9
 100.0%
1
  50.0%
5
  62.5%
42
  91.3%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent were events between first dose of study drug and up to the follow up visit (up to 36 days in Part A, 49 days in Part B and C), that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8 6 6 6 6 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
AEs 1 3 2 6 4 6 10 8 2 6
SAEs 0 0 0 0 0 0 0 0 0 0
2.Primary Outcome
Title Number of Participants With Abnormal Physical Examinations Findings
Hide Description Full physical examination included head, ears, eyes, nose, mouth, skin, heart, lung, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Abnormality in physical examinations was based on investigator's discretion.
Time Frame Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8 6 6 6 6 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
1 5 0 0 0 6 8 5 0 4
3.Primary Outcome
Title Number of Participants With Abnormal Neurological Examinations Findings
Hide Description The neurological examination included the assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait. Abnormality in neurological examinations was based on investigator's discretion.
Time Frame Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8 6 6 6 6 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0 0 0 0 0
4.Primary Outcome
Title Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline
Hide Description C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at baseline were reported.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.
Arm/Group Title Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
5.Primary Outcome
Title Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 7
Hide Description C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 7 were reported.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.
Arm/Group Title Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
6.Primary Outcome
Title Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 14
Hide Description C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 14 were reported.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.
Arm/Group Title Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
7.Primary Outcome
Title Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 19
Hide Description C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 19 were reported.
Time Frame Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.
Arm/Group Title Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
8.Primary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Hide Description Criteria for abnormal values of ECG parameters: maximum pulse rate (PR) interval greater than or equal to (>=)300 milliseconds (msec); maximum PR interval increase from baseline (IFB): >=25 percent (%) when baseline was greater than (>)200 msec; or >=50 % when baseline was greater than (>)200 msec, maximum QRS interval >=140 msec and QRS interval IFB: >=50%. QT interval using Fridericia's correction (QTcF) ranges from 450 msec to maximum less than (<)480 msec, less than or equal to (<=) 480 msec to maximum <500 msec and maximum >=500 msec, maximum QTcF interval IFB range from <=30 to <60 msec and maximum >=60 msec. Only categories which included at least 1 participant with abnormality are reported in this outcome measure.
Time Frame Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8 6 6 6 6 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
Maximum QTCF Interval: 450 to <480 msec 0 0 0 0 0 1 0 0 0 1
Maximum QTCF Interval IFB: <=30 to <60 msec 0 0 0 1 0 0 0 1 0 0
9.Primary Outcome
Title Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry
Hide Description In all Periods of Part A, continuous cardiac monitoring was maintained for 8 hours (or longer if considered clinically necessary by the investigator) following dose administration on Day 1. All abnormal cardiac rhythms were recorded and reviewed by the study physician for the presence of rhythms of potential clinical concern.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
Arm/Group Title Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 8 6 6 6 6
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
10.Primary Outcome
Title Number of Participants With Vital Sign Abnormalities
Hide Description Criteria for vital signs abnormalities: systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), diastolic blood pressure (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum IFB in Supine SBP >=30 mmHg, Maximum decrease from baseline (DFB) in Supine SBP >=30 mmHg, maximum DFB in Supine DBP >=20 mmHg.
Time Frame Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8 6 6 6 6 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
Supine SBP: <90 mmHg 0 0 0 0 0 0 0 0 0 1
Supine DBP: <50 mmHg 0 0 0 0 0 0 0 1 0 1
Supine PR: <40 bpm 0 0 0 0 0 0 0 1 0 0
Maximum IFB in Supine SBP: >=30 mmHg 0 0 0 0 0 0 0 1 1 0
Maximum DFB in Supine SBP: >=30 mmHg 0 0 0 0 0 0 0 0 0 2
Maximum DFB in Supine DBP: >=20 mmHg 0 0 0 1 0 0 0 1 0 1
11.Primary Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description Abnormalities criteria:hematology(hemoglobin; hematocrit; RBC<0.8*lower limit of normal [LLN]; platelets<0.5*LLN,>1.75*upper limit of normal [ULN]; WBC<0.6*LLN,>1.5*ULN; lymphocytes; neutrophils; basophils; eosinophils; monocytes<0.8*LLN,>1.2*ULN; coagulation(prothrombin ratio>1.1*ULN), liver(bilirubin>1.5*ULN; aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase; gamma GT>0.3*ULN; protein; albumin<0.8*LLN,>1.2*ULN); renal(blood urea nitrogen, creatinine>1.3*ULN; uric acid>1.2*ULN); electrolytes(sodium<0.95*LLN,>1.05*ULN; potassium; chloride; calcium; bicarbonate<0.9*LLN,>1.1*ULN), chemistry(glucose<0.6*LLN,>1.5* ULN); urinalysis(pH <4.5,>8; glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte, esterase>1; WBC; bacteria>=20, epithelial cells>=6; granular casts, hyaline casts, red cell casts, white cell casts>1; lipids(cholesterol[C], LDL-C>1.3*ULN; HDL-C<0.8*LLN, triglycerides>1.3*ULN); hormones(T4, T3, T4, TSH<0.8*LLN,>1.2*ULN).
Time Frame Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description:
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8 6 6 6 6 7 12 9 2 8
Measure Type: Number
Unit of Measure: participants
6 5 2 3 5 5 11 8 1 7
12.Secondary Outcome
Title Part A: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
Hide Description [Not Specified]
Time Frame pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter
643.2
(19%)
1436
(10%)
1829
(19%)
630.2
(9%)
13.Secondary Outcome
Title Part A: Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-06751979
Hide Description Area under the plasma concentration-time profile from time zero to the time of last measured concentration (AUClast).
Time Frame pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter
20500
(19%)
41710
(18%)
58190
(14%)
20170
(13%)
14.Secondary Outcome
Title Part A: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06751979
Hide Description AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Time Frame pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter
22850
(17%)
44980
(17%)
63420
(9%)
23260
(15%)
15.Secondary Outcome
Title Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979
Hide Description Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in milligram) administered to a participant.
Time Frame pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (nanogram per milliliter) per milligram
3.218
(19%)
3.592
(10%)
3.387
(19%)
3.154
(9%)
16.Secondary Outcome
Title Part A: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06751979
Hide Description AUClast(dn) was calculated by dividing AUClast by the exact dose of PF-06751979 (in mg) administered to a participant. AUClast was area under the plasma concentration-time profile from time zero to the time of last measured concentration.
Time Frame pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (nanogram*hour/milliliter) per milligram
102.6
(19%)
104.2
(18%)
107.9
(14%)
100.9
(13%)
17.Secondary Outcome
Title Part A: Dose Normalized Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf [dn]) of PF-06751979
Hide Description AUCinf (dn) was calculated by dividing AUCinf by the exact dose of PF-06751979 (in mg) administered to a participant. AUCinf was area under the plasma concentration-time profile from time zero extrapolated to infinite time (0-inf).
Time Frame pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (nanogram*hour/milliliter) per milligram
114.1
(17%)
112.4
(17%)
117.6
(9%)
116.4
(15%)
18.Secondary Outcome
Title Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
Hide Description [Not Specified]
Time Frame pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Median (Full Range)
Unit of Measure: hours
4.00
(2.00 to 6.07)
3.02
(2.00 to 4.00)
3.01
(2.00 to 6.02)
6.00
(4.00 to 8.00)
19.Secondary Outcome
Title Part A: Plasma Decay Half-Life (t1/2) of PF-06751979
Hide Description Plasma decay half-life is the time duration for the plasma concentration of PF-06751979 to decrease by one-half of its original concentration.
Time Frame pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hours
35.20  (8.9731) 34.70  (8.9749) 35.85  (8.1028) 33.38  (6.2474)
20.Secondary Outcome
Title Part A: Apparent Clearance (CL/F) of PF-06751979
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliter per minute
145.8
(2.00% to 6.07%)
148.3
(2.00% to 4.00%)
142.0
(2.00% to 6.02%)
143.3
(4.00% to 8.00%)
21.Secondary Outcome
Title Part A: Apparent Volume of Distribution (Vz/F) of PF-06751979
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed
Hide Arm/Group Description:
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
Overall Number of Participants Analyzed 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
433.7
(2.00% to 6.07%)
433.0
(2.00% to 4.00%)
431.1
(2.00% to 6.02%)
408.1
(4.00% to 8.00%)
22.Secondary Outcome
Title Part B: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
Hide Description [Not Specified]
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time points for each arm.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter
Day 1 Number Analyzed 12 participants 9 participants
442.7
(20%)
983.2
(18%)
Day 7 Number Analyzed 12 participants 9 participants
818.7
(19%)
2000
(14%)
Day 14 Number Analyzed 12 participants 8 participants
837.6
(16%)
1869
(14%)
23.Secondary Outcome
Title Part B: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979
Hide Description Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter
Day 1 Number Analyzed 12 participants 9 participants
6380
(15%)
13260
(18%)
Day 7 Number Analyzed 12 participants 9 participants
13810
(16%)
31210
(14%)
Day 14 Number Analyzed 12 participants 8 participants
13990
(14%)
29470
(12%)
24.Secondary Outcome
Title Part B: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
Hide Description [Not Specified]
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Median (Full Range)
Unit of Measure: hours
Day 1 Number Analyzed 12 participants 9 participants
4.00
(2.00 to 6.03)
4.00
(2.00 to 4.00)
Day 7 Number Analyzed 12 participants 9 participants
3.00
(2.00 to 6.00)
2.00
(2.00 to 4.00)
Day 14 Number Analyzed 12 participants 8 participants
4.00
(2.00 to 12.00)
4.00
(2.00 to 4.00)
25.Secondary Outcome
Title Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979
Hide Description Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered to a participant.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (nanogram per milliliter) per milligram
Day 1 Number Analyzed 12 participants 9 participants
3.541
(20%)
3.576
(18%)
Day 7 Number Analyzed 12 participants 9 participants
6.549
(19%)
7.272
(14%)
Day 14 Number Analyzed 12 participants 8 participants
6.702
(16%)
6.794
(14%)
26.Secondary Outcome
Title Part B: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979
Hide Description Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. AUCtau (dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (nanogram*hour/milliliter)/milligram
Day 1 Number Analyzed 12 participants 9 participants
51.04
(15%)
48.21
(18%)
Day 7 Number Analyzed 12 participants 9 participants
110.4
(16%)
113.5
(15%)
Day 14 Number Analyzed 12 participants 8 participants
111.8
(14%)
107.1
(12%)
27.Secondary Outcome
Title Part B: Apparent Clearance (CL/F) of PF-06751979
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliter per minute
Day 7 Number Analyzed 12 participants 9 participants
151.0
(16%)
146.9
(14%)
Day 14 Number Analyzed 12 participants 8 participants
149.0
(14%)
155.3
(13%)
28.Secondary Outcome
Title Part B: Minimum Observed Plasma Concentration (Cmin) of PF-06751979
Hide Description [Not Specified]
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter
Day 7 Number Analyzed 12 participants 9 participants
388.4
(17%)
857.3
(15%)
Day 14 Number Analyzed 12 participants 8 participants
390.3
(18%)
868.5
(15%)
29.Secondary Outcome
Title Part B: Peak-to-Trough Ratio of PF-06751979
Hide Description Peak-to-trough ratio was calculated by dividing Cmax with Cmin of PF-06751979. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
Day 7 Number Analyzed 12 participants 9 participants
2.111
(10%)
2.332
(8%)
Day 14 Number Analyzed 12 participants 8 participants
2.145
(11%)
2.151
(9%)
30.Secondary Outcome
Title Part B: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979
Hide Description Rac for AUCtau for Day 7 was calculated as: AUCtau on Day 7 divided by AUCtau on Day 1. Rac for AUCtau for Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
Day 7 Number Analyzed 12 participants 9 participants
2.165
(9%)
2.355
(15%)
Day 14 Number Analyzed 12 participants 8 participants
2.190
(11%)
2.265
(11%)
31.Secondary Outcome
Title Part B: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979
Hide Description Rac for Cmax on Day 7 was calculated as: Cmax on Day 7 divided by Cmax on Day 1 and Rac for Cmax on Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
Day 7 Number Analyzed 12 participants 9 participants
1.849
(16%)
2.033
(7%)
Day 14 Number Analyzed 12 participants 8 participants
1.892
(14%)
1.923
(9%)
32.Secondary Outcome
Title Part B: Plasma Decay Half-Life (t1/2) of PF-06751979
Hide Description Plasma decay half-life is the time duration for the plasma concentration of PF-06751979 to decrease by one-half of its original concentration.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 8
Mean (Standard Deviation)
Unit of Measure: hour
30.73  (5.7464) 37.79  (7.7261)
33.Secondary Outcome
Title Part B: Apparent Volume of Distribution (Vz/F) of PF-06751979
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 12 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
390.5
(2.00% to 12.00%)
498.3
(2.00% to 4.00%)
34.Secondary Outcome
Title Part C: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
Hide Description [Not Specified]
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter
Day 1
377.1
(2.00% to 12.00%)
Day 14
879.4
(28%)
35.Secondary Outcome
Title Part C: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979
Hide Description Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour per milliliter
Day 1
5238
(2.00% to 12.00%)
Day 14
14750
(23%)
36.Secondary Outcome
Title Part C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
Hide Description [Not Specified]
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: hours
Day 1
4.00
(2.00 to 4.03)
Day 14
4.00
(2.00 to 4.03)
37.Secondary Outcome
Title Part C: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979
Hide Description Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered to a participant.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (nanogram per milliliter) per milligram
Day 1
3.019
(2.00% to 4.03%)
Day 14
7.035
(2.00% to 4.03%)
38.Secondary Outcome
Title Part C: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979
Hide Description Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. AUCtau (dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (nanogram*hour/milliliter)/milligram
Day 1
41.93
(2.00% to 4.03%)
Day 14
118.0
(2.00% to 4.03%)
39.Secondary Outcome
Title Part C: Apparent Oral Clearance (CL/F)
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliter per minute
141.4
(2.00% to 4.03%)
40.Secondary Outcome
Title Part C: Minimum Observed Plasma Concentration (Cmin) of PF-06751979
Hide Description Minimum observed concentration during the dosing interval.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter
429.9
(2.00% to 4.03%)
41.Secondary Outcome
Title Part C: Peak-to-Trough Ratio of PF-06751979
Hide Description Peak-to-trough ratio was calculated by dividing Cmax with Cmin of PF-06751979. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
2.045
(2.00% to 4.03%)
42.Secondary Outcome
Title Part C: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979
Hide Description Rac for AUCtau at Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
2.814
(2.00% to 4.03%)
43.Secondary Outcome
Title Part C: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979
Hide Description Rac for Cmax on Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
2.332
(2.00% to 4.03%)
44.Secondary Outcome
Title Part C: Plasma Decay Half-Life (t1/2) of PF-06751979
Hide Description Plasma decay half-life was the time duration for the plasma concentration to decrease by one-half of its original concentration.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: hours
40.76  (3.9042)
45.Secondary Outcome
Title Part C: Apparent Volume of Distribution (Vz/F) of PF-06751979
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time Frame pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Arm/Group Title Part C: PF-06751979 125 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
496.1
(2.00% to 4.03%)
46.Secondary Outcome
Title Part B: Amount of PF-06751979 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)
Hide Description Aetau was the amount of drug excreted unchanged in urine during the dosing interval tau, where tau was 24 hours.
Time Frame 0-24 hours on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milligram
12.93
(38%)
25.93
(28%)
47.Secondary Outcome
Title Part B: Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)
Hide Description Aetau% was calculated as: 100*Aetau/dose. Aetau was the amount of drug excreted unchanged in urine during the dosing interval tau, where tau was 24 hours.
Time Frame 0-24 hours on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: percentage of dose excreated
10.36
(38%)
9.429
(28%)
48.Secondary Outcome
Title Part B: Renal Clearance of PF-06751979
Hide Description Renal clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated in urine. It was calculated as amount of drug excreted unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.
Time Frame 0-24 hours on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol.
Arm/Group Title Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 9 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliter per minute
15.54
(37%)
14.68
(34%)
49.Secondary Outcome
Title Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
Hide Description ABeta is the peptide fragment of the amyloid precursor protein. Percent change from baseline in CSF concentration of ABeta fragments (ABeta 1-38, ABeta 1-40, ABeta 1-42, ABeta total, ABeta x-38, ABeta x-40, ABeta x-42, soluble amyloid precursor protein alpha (sAPP-alpha), soluble amyloid precursor protein beta (sAPP-beta) at Day 14 was reported in this outcome measure.
Time Frame Baseline, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic CSF concentration population: all enrolled and treated participants who had at least 1 measureable CSF ABeta concentration. Number of participants analyzed= participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part A and C, as pre specified in protocol.
Arm/Group Title Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg
Hide Arm/Group Description:
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
Overall Number of Participants Analyzed 6 12 8
Mean (Standard Error)
Unit of Measure: percent change
ABeta 1-38 -4.223  (0.0669) -80.324  (0.0472) -87.935  (0.0579)
ABeta 1-40 -10.031  (0.0746) -85.452  (0.0536) -92.927  (0.0689)
ABeta 1-42 -10.335  (0.0789) -86.383  (0.0587) -93.607  (0.0758)
ABeta x-38 -12.362  (0.0708) -82.003  (0.0513) -90.106  (0.0643)
ABeta x-40 -9.785  (0.0673) -80.998  (0.0478) -87.622  (0.0591)
ABeta x-42 -10.874  (0.0539) -81.861  (0.0385) -86.618  (0.0472)
sAPP-alpha -8.237  (0.0655) 58.653  (0.0480) 81.737  (0.0604)
sAPP-beta -5.553  (0.0545) -81.266  (0.0390) -84.304  (0.0485)
ABeta total -7.911  (0.0492) -80.116  (0.0348) -86.523  (0.0428)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 125 mg
Comments ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -79.456
Confidence Interval (2-Sided) 80%
-81.56 to -77.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0819
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 275 mg
Comments ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -87.403
Confidence Interval (2-Sided) 80%
-88.80 to -85.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0887
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 125 mg
Comments ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -83.830
Confidence Interval (2-Sided) 80%
-85.65 to -81.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0905
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 275 mg
Comments ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -92.138
Confidence Interval (2-Sided) 80%
-93.15 to -90.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1041
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 125 mg
Comments ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -84.814
Confidence Interval (2-Sided) 80%
-86.64 to -82.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0971
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 275 mg
Comments ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -92.870
Confidence Interval (2-Sided) 80%
-93.85 to -91.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1114
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 125 mg
Comments ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -79.465
Confidence Interval (2-Sided) 80%
-81.69 to -76.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0870
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 275 mg
Comments ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -88.711
Confidence Interval (2-Sided) 80%
-90.06 to -87.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0963
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 125 mg
Comments ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -78.936
Confidence Interval (2-Sided) 80%
-81.11 to -76.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0824
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 275 mg
Comments ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -86.280
Confidence Interval (2-Sided) 80%
-87.82 to -84.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0899
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 125 mg
Comments ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -79.648
Confidence Interval (2-Sided) 80%
-81.36 to -77.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0664
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 275 mg
Comments ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -84.985
Confidence Interval (2-Sided) 80%
-86.34 to -83.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0715
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 125 mg
Comments sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value 72.893
Confidence Interval (2-Sided) 80%
55.37 to 92.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0809
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 275 mg
Comments sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value 98.049
Confidence Interval (2-Sided) 80%
75.92 to 122.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0897
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 125 mg
Comments sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -80.164
Confidence Interval (2-Sided) 80%
-81.84 to -78.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0668
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 275 mg
Comments sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -83.381
Confidence Interval (2-Sided) 80%
-84.92 to -81.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0733
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 125 mg
Comments Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -78.408
Confidence Interval (2-Sided) 80%
-80.06 to -76.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0602
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: PF-06751979 275 mg
Comments Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent change from baseline
Estimated Value -85.365
Confidence Interval (2-Sided) 80%
-86.57 to -84.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0653
Estimation Comments [Not Specified]
Time Frame Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Hide Arm/Group Description All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period. Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication. Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
All-Cause Mortality
Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/7 (0.00%)   0/12 (0.00%)   0/9 (0.00%)   0/2 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/7 (0.00%)   0/12 (0.00%)   0/9 (0.00%)   0/2 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: Placebo Part A: PF-06751979 200 mg Part A: PF-06751979 400 mg Part A: PF-06751979 540 mg Part A: PF-06751979 200 mg Fed Part B: Placebo Part B: PF-06751979 125 mg Part B: PF-06751979 275 mg Part C: Placebo Part C: PF-06751979 125 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   3/6 (50.00%)   2/6 (33.33%)   6/6 (100.00%)   4/6 (66.67%)   6/7 (85.71%)   10/12 (83.33%)   8/9 (88.89%)   2/2 (100.00%)   6/8 (75.00%) 
Cardiac disorders                     
Atrioventricular block first degree * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Eye disorders                     
Conjunctival hyperaemia * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Visual impairment * 1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Blepharospasm * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Eye movement disorder * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Vision blurred * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders                     
Constipation * 1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Dyspepsia * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Nausea * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Diarrhoea * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/2 (50.00%)  0/8 (0.00%) 
Gingival pain * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Paraesthesia oral * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
General disorders                     
Discomfort * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Fatigue * 1  0/8 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  2/12 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Hunger * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Vessel puncture site erythema * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Malaise * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Infections and infestations                     
Ear infection * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Folliculitis * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Fungal skin infection * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Hordeolum * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Nasopharyngitis * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Gastroenteritis * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Pulpitis dental * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications                     
Procedural pain * 1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  2/12 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Skin abrasion * 1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Arthropod bite * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Contusion * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Investigations                     
Aspartate aminotransferase increased * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Alanine aminotransferase increased * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Hepatic enzyme increased * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Muscle spasms * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Back pain * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  2/12 (16.67%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Musculoskeletal discomfort * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  3/12 (25.00%)  2/9 (22.22%)  0/2 (0.00%)  0/8 (0.00%) 
Myalgia * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/2 (50.00%)  0/8 (0.00%) 
Neck pain * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Pain in extremity * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Nervous system disorders                     
Dizziness * 1  1/8 (12.50%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/12 (0.00%)  0/9 (0.00%)  1/2 (50.00%)  0/8 (0.00%) 
Dizziness postural * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Headache * 1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/6 (0.00%)  2/7 (28.57%)  3/12 (25.00%)  1/9 (11.11%)  0/2 (0.00%)  1/8 (12.50%) 
Paraesthesia * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Poor quality sleep * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Presyncope * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Somnolence * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Psychiatric disorders                     
Abnormal dreams * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  1/2 (50.00%)  0/8 (0.00%) 
Daydreaming * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Insomnia * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/12 (8.33%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Nightmare * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Dry throat * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Oropharyngeal pain * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Throat irritation * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders                     
Blister * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Dry skin * 1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Skin irritation * 1  0/8 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Acne * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  3/9 (33.33%)  0/2 (0.00%)  0/8 (0.00%) 
Erythema * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  1/8 (12.50%) 
Pruritus * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Rash maculo-papular * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/2 (0.00%)  0/8 (0.00%) 
Vascular disorders                     
Hot flush * 1  0/8 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
Haematoma * 1  0/8 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/12 (0.00%)  0/9 (0.00%)  0/2 (0.00%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02793232    
Other Study ID Numbers: B8271004
2016-000325-39 ( EudraCT Number )
First Submitted: June 3, 2016
First Posted: June 8, 2016
Results First Submitted: December 22, 2017
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018