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Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01673178
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : January 14, 2015
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Melliuts, Type 2
Interventions Other: Placebo
Drug: 25 mg PF-05231023
Drug: 50 mg PF-05231023
Drug: 100 mg PF-05231023
Drug: 150 mg PF-05231023
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Period Title: Overall Study
Started 22 21 21 22 21
Completed 19 19 18 14 19
Not Completed 3 2 3 8 2
Reason Not Completed
Lost to Follow-up             0             1             0             0             0
Withdrawal by Subject             0             0             1             4             2
Protocol Violation             1             1             0             1             0
Adverse Event             1             0             0             2             0
Other             1             0             2             1             0
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg Total
Hide Arm/Group Description Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4. Total of all reporting groups
Overall Number of Baseline Participants 22 21 21 22 21 107
Hide Baseline Analysis Population Description
Analysis set included all participants who received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 21 participants 22 participants 21 participants 107 participants
52.8  (8.0) 54.6  (8.3) 53.4  (9.5) 53.0  (7.4) 53.2  (8.0) 53.4  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 21 participants 22 participants 21 participants 107 participants
Female
11
  50.0%
7
  33.3%
4
  19.0%
5
  22.7%
4
  19.0%
31
  29.0%
Male
11
  50.0%
14
  66.7%
17
  81.0%
17
  77.3%
17
  81.0%
76
  71.0%
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 events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame Baseline up to 28 days after last dose
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 Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 22 21
Measure Type: Number
Unit of Measure: participants
AEs 11 15 10 13 12
SAEs 1 2 0 1 0
2.Primary Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil: <0.8*LLN, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 20/High Power Field [HPF]).
Time Frame Baseline up to Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 20 21
Measure Type: Number
Unit of Measure: participants
18 17 17 12 15
3.Primary Outcome
Title Number of Participants With Clinically Significant Vital Sign Abnormalities
Hide Description Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg; >=20 mmHg maximum increase and decrease from baseline in same posture.
Time Frame Baseline up to Day 49
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 Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 22 21
Measure Type: Number
Unit of Measure: participants
Supine SBP: <90 mmHg 1 1 0 0 0
Supine DBP: <50 mmHg 0 0 1 0 0
Maximum Increase in Supine SBP: >=30 mmHg 1 5 4 6 2
Maximum Increase in Supine DBP: >=20 mmHg 2 4 3 1 2
Maximum Decrease in Supine SBP: >=30 mmHg 3 2 2 0 0
Maximum Decrease in Supine DBP: >=20 mmHg 5 1 4 4 2
Supine Pulse Rate: <40 bpm 0 0 0 0 0
Supine Pulse Rate: >120 bpm 0 0 0 0 0
4.Primary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram Findings
Hide Description Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25 percent (%) increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=140 msec or >=50% increase from baseline; QT interval >=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to <480 msec, 480 to <500 msec, >=500 msec or >=30 msec but <60 msec increase from baseline or >=60 msec increase from baseline.
Time Frame Baseline up to Day 49
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 Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 22 21
Measure Type: Number
Unit of Measure: participants
Maximum PR interval: >=300 msec 0 0 0 0 0
Maximum PR interval increase : 25% or 50% 0 0 0 0 0
Maximum QRS complex: >=140 msec 0 0 0 0 0
Maximum QRS complex increase from baseline:>=50% 0 0 0 0 0
Maximum QT interval: >=500 msec 0 0 0 0 0
Maximum QTcF interval: 450-<480 msec 4 3 3 1 3
Maximum QTcF interval: 480-<500 msec 0 0 0 0 0
Maximum QTcF interval: >=500 msec 0 0 0 0 0
Maximum QTcF interval increase: >= 30 to <60 msec 7 4 1 1 4
Maximum QTCF interval increase: >=60 msec 0 0 0 0 0
5.Primary Outcome
Title Number of Participants With Abnormal Physical Examinations
Hide Description Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.
Time Frame Baseline up to Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Physical examination data reported in this study was for identification of adverse events and were reported as an adverse event in the adverse event section.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Thyroid Stimulating Hormone (TSH) Level at Baseline
Hide Description Results are reported in micro international units per milliliter (mcIU/mL).
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.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 22 21
Mean (Standard Deviation)
Unit of Measure: mcIU/mL
1.57  (0.65) 2.14  (1.25) 1.96  (1.06) 1.88  (1.02) 2.06  (0.87)
7.Primary Outcome
Title Thyroid Stimulating Hormone (TSH) Level at Day 1
Hide Description [Not Specified]
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. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 21 21
Mean (Standard Deviation)
Unit of Measure: mcIU/mL
1.96  (0.95) 2.19  (1.10) 2.40  (1.40) 2.26  (1.27) 4.21  (6.67)
8.Primary Outcome
Title Thyroid Stimulating Hormone (TSH) Level at Day 25
Hide Description [Not Specified]
Time Frame Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 20 18 15 19
Mean (Standard Deviation)
Unit of Measure: mcIU/mL
2.70  (3.68) 2.13  (1.07) 2.43  (0.87) 2.52  (1.38) 4.06  (5.69)
9.Primary Outcome
Title Thyroid Stimulating Hormone (TSH) Level at Day 39
Hide Description [Not Specified]
Time Frame Day 39
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 18 19 18 14 19
Mean (Standard Deviation)
Unit of Measure: mcIU/mL
3.69  (8.11) 2.08  (1.54) 2.17  (1.12) 2.50  (1.37) 3.10  (3.28)
10.Primary Outcome
Title Thyroid Stimulating Hormone (TSH) Level at Day 49
Hide Description [Not Specified]
Time Frame Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 18 19 18 14 18
Mean (Standard Deviation)
Unit of Measure: mcIU/mL
3.42  (7.45) 1.98  (1.16) 2.43  (1.78) 2.55  (1.06) 3.10  (2.03)
11.Primary Outcome
Title Phosphate Level at Baseline
Hide Description [Not Specified]
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. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 20 22 21
Median (Full Range)
Unit of Measure: milligram per deciliter (mg/dL)
4.1
(3.0 to 5.1)
3.8
(3.1 to 5.0)
3.9
(3.0 to 5.3)
4.0
(3.0 to 5.2)
4.0
(2.9 to 4.5)
12.Primary Outcome
Title Change From Baseline in Phosphate Level at Day 8
Hide Description [Not Specified]
Time Frame Baseline, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 20 20 17 19
Median (Full Range)
Unit of Measure: mg/dL
-0.2
(-1.4 to 0.8)
-0.4
(-1.4 to 0.6)
0.1
(-0.8 to 0.6)
0.0
(-1.0 to 0.8)
-0.3
(-1.0 to 1.0)
13.Primary Outcome
Title Change From Baseline in Phosphate Level at Day 15
Hide Description [Not Specified]
Time Frame Baseline, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 20 16 17 20
Median (Full Range)
Unit of Measure: mg/dL
-0.2
(-1.2 to 0.8)
-0.2
(-2.3 to 0.7)
0.2
(-1.6 to 1.3)
-0.1
(-0.9 to 0.9)
-0.2
(-0.8 to 0.5)
14.Primary Outcome
Title Change From Baseline in Phosphate Level at Day 25
Hide Description [Not Specified]
Time Frame Baseline, Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 20 17 15 19
Median (Full Range)
Unit of Measure: mg/dL
-0.1
(-1.1 to 0.8)
-0.2
(-1.1 to 0.5)
0.2
(-0.6 to 1.1)
0.1
(-0.6 to 0.8)
0.0
(-0.7 to 0.4)
15.Primary Outcome
Title Change From Baseline in Phosphate Level at Day 49
Hide Description [Not Specified]
Time Frame Baseline, Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 19 17 14 19
Median (Full Range)
Unit of Measure: mg/dL
-0.40
(-1.50 to 0.30)
-0.40
(-1.40 to 1.00)
-0.20
(-1.20 to 1.20)
-0.30
(-1.10 to 0.70)
-0.10
(-0.90 to 0.90)
16.Primary Outcome
Title Creatine Phosphokinase (CPK) Level at Baseline
Hide Description [Not Specified]
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. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 20 22 21
Median (Full Range)
Unit of Measure: units per liter (U/L)
73
(26 to 471)
94
(42 to 493)
94
(38 to 399)
103
(45 to 699)
108
(44 to 173)
17.Primary Outcome
Title Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8
Hide Description [Not Specified]
Time Frame Baseline, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 20 20 17 19
Median (Full Range)
Unit of Measure: U/L
10
(-260 to 143)
32
(-21 to 850)
13
(-70 to 245)
25
(-175 to 92)
13
(-27 to 7614)
18.Primary Outcome
Title Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15
Hide Description [Not Specified]
Time Frame Baseline, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 20 16 16 20
Median (Full Range)
Unit of Measure: U/L
28
(-34 to 852)
20
(-34 to 629)
7
(-97 to 243)
22
(-113 to 238)
18
(-62 to 248)
19.Primary Outcome
Title Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25
Hide Description [Not Specified]
Time Frame Baseline, Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 18 19 16 15 18
Median (Full Range)
Unit of Measure: U/L
-5
(-246 to 32)
-6
(-38 to 48)
-15
(-110 to 19)
-8
(-54 to 771)
-3
(-90 to 39)
20.Primary Outcome
Title Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49
Hide Description [Not Specified]
Time Frame Baseline, Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 19 17 14 19
Median (Full Range)
Unit of Measure: U/L
21
(-141 to 2214)
40
(-30 to 494)
27
(-85 to 292)
43
(-16 to 216)
10
(-62 to 139)
21.Primary Outcome
Title Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline
Hide Description [Not Specified]
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. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 21 21
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (NG/ML)
PINP 46.3  (15.6) 41.7  (17.0) 44.7  (19.4) 45.0  (19.8) 44.6  (17.6)
CTX 0.35  (0.11) 0.33  (0.16) 0.35  (0.15) 0.38  (0.20) 0.37  (0.19)
22.Primary Outcome
Title Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25
Hide Description [Not Specified]
Time Frame Baseline, Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 20 18 15 19
Mean (Standard Deviation)
Unit of Measure: percent change
PINP -0.8  (13.5) -14.5  (11.0) -13.4  (13.3) -17.6  (12.8) -19.8  (9.2)
CTX 5.2  (15.5) 2.3  (19.7) 8.0  (23.6) 7.3  (17.7) 7.9  (19.4)
23.Primary Outcome
Title Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39
Hide Description [Not Specified]
Time Frame Baseline, Day 39
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 18 19 18 14 19
Mean (Standard Deviation)
Unit of Measure: percent change
PINP -2.8  (13.6) -9.8  (12.4) -6.6  (15.6) -10.3  (12.8) -11.0  (13.5)
CTX -7.3  (21.7) -4.2  (21.1) -3.5  (20.2) -13.1  (18.2) -3.0  (31.5)
24.Primary Outcome
Title Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49
Hide Description [Not Specified]
Time Frame Baseline, Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who receive at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 18 19 18 14 18
Mean (Standard Deviation)
Unit of Measure: percent change
PINP -3.0  (16.4) -9.4  (16.9) -1.3  (20.3) -4.6  (15.0) -7.4  (18.3)
CTX 1.5  (20.8) 7.5  (30.9) -3.9  (33.8) -16.6  (15.3) -5.3  (25.0)
25.Primary Outcome
Title Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline
Hide Description [Not Specified]
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. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 21 21
Mean (Standard Deviation)
Unit of Measure: microgram per liter (mcg/l)
Blood Osteocalcin 18.8  (5.4) 19.2  (5.9) 18.5  (6.3) 20.2  (8.2) 19.9  (7.0)
Bone-Specific Alkaline Phosphatase 13.0  (5.7) 11.7  (3.9) 11.2  (4.8) 10.0  (3.0) 11.2  (4.2)
26.Primary Outcome
Title Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25
Hide Description [Not Specified]
Time Frame Baseline, Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 20 18 15 19
Mean (Standard Deviation)
Unit of Measure: percent change
Blood Osteocalcin -2.4  (8.2) -12.2  (9.6) -6.4  (14.0) -7.1  (11.2) -4.8  (8.2)
Bone-Specific Alkaline Phosphatase -4.3  (14.5) -6.6  (17.0) -0.4  (15.4) -5.1  (16.2) -7.1  (13.1)
27.Primary Outcome
Title Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39
Hide Description [Not Specified]
Time Frame Baseline, Day 39
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 18 19 18 14 19
Mean (Standard Deviation)
Unit of Measure: percent change
Blood Osteocalcin -1.8  (12.6) -10.7  (9.1) -11.6  (12.4) -14.7  (11.6) -13.4  (13.3)
Bone-Specific Alkaline Phosphatase -5.0  (20.7) -5.1  (11.2) 3.0  (18.9) -13.0  (19.0) -8.1  (12.4)
28.Primary Outcome
Title Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49
Hide Description [Not Specified]
Time Frame Baseline, Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 18 19 18 14 18
Mean (Standard Deviation)
Unit of Measure: percent change
Blood Osteocalcin -4.5  (11.9) -10.7  (8.5) -5.1  (17.1) -11.0  (9.3) -4.8  (12.3)
Bone-Specific Alkaline Phosphatase -3.8  (20.6) -3.9  (14.4) -0.9  (13.2) -9.6  (16.6) 0.7  (27.1)
29.Primary Outcome
Title Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline
Hide Description [Not Specified]
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. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 21 21 21 21 21
Mean (Standard Deviation)
Unit of Measure: units per liter (U/L)
2.97  (0.53) 2.72  (0.48) 3.10  (0.73) 2.78  (0.62) 3.08  (0.65)
30.Primary Outcome
Title Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25
Hide Description [Not Specified]
Time Frame Baseline, Day 25
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 18 20 18 15 19
Mean (Standard Deviation)
Unit of Measure: percent change
1.3  (9.4) -1.7  (12.6) 1.9  (11.0) -0.4  (10.6) -1.4  (10.9)
31.Primary Outcome
Title Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39
Hide Description [Not Specified]
Time Frame Baseline, Day 39
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 17 19 18 14 19
Mean (Standard Deviation)
Unit of Measure: percent change
0.5  (10.7) -0.4  (11.6) 0.2  (10.0) -2.9  (9.9) 3.7  (16.2)
32.Primary Outcome
Title Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49
Hide Description [Not Specified]
Time Frame Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 17 19 18 14 18
Mean (Standard Deviation)
Unit of Measure: percent change
-2.4  (10.2) 3.1  (18.0) -0.8  (12.0) -0.1  (9.3) -1.1  (15.8)
33.Primary Outcome
Title Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline
Hide Description [Not Specified]
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. Here "n" signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 22 21
Mean (Standard Deviation)
Unit of Measure: milligram per 24 hours (mg/24hr)
Urine Calcium (n=20, 20, 20, 20, 21) 296.4  (143.4) 202.1  (104.5) 224.3  (122.2) 205.3  (100.1) 207.4  (112.9)
Urine Phosphate (n=21, 20, 20, 21, 21) 922.1  (430.3) 673.2  (228.3) 859.1  (318.7) 795.4  (294.4) 755.3  (292.1)
34.Primary Outcome
Title Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24
Hide Description [Not Specified]
Time Frame Day 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "n" signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 22 21 21 22 21
Mean (Standard Deviation)
Unit of Measure: mg/24 hours
Urine Calcium (n=17, 17, 16, 15, 19) -29.3  (106.3) -9.1  (69.6) 38.0  (131.9) 8.2  (69.0) 5.1  (89.7)
Urine Phosphate (n=18, 16, 16, 15, 18) 18.8  (276.0) 225.8  (283.4) 241.6  (436.0) 244.1  (363.4) 484.4  (514.7)
35.Primary Outcome
Title Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1
Hide Description Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who receive at least 1 dose of study medication. Here "n" signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 21 21 22 21
Measure Type: Number
Unit of Measure: participants
Anti-PF- 05231023 Antibodies (n=21, 21, 22, 21) 0 0 0 0
Neutralizing Antibodies (n=0, 0, 0, 1) NA [1]  NA [1]  NA [1]  0
[1]
Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.
36.Primary Outcome
Title Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39
Hide Description Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.
Time Frame Day 39
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "n" signifies those participants who were evaluable for specified antibodies for each arm, respectively and "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 18 14 19
Measure Type: Number
Unit of Measure: participants
Anti-PF- 05231023 Antibodies (n=19, 18, 14, 19) 0 0 0 1
Neutralizing Antibodies (n=0, 0, 1, 1) NA [1]  NA [1]  0 0
[1]
Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.
37.Primary Outcome
Title Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49
Hide Description [Not Specified]
Time Frame Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication. Here "n" signifies those participants who were evaluable for specified antibodies for each arm, respectively and "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 18 14 19
Measure Type: Number
Unit of Measure: participants
Anti-PF- 05231023 Antibodies (n=19, 18, 14, 19) 0 1 0 1
Neutralizing Antibodies (n=0, 2, 0, 1) NA [1]  1 NA [1]  0
[1]
Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.
38.Secondary Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose
Hide Description AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 20 21 17 20
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*hr/mL)
PF-05231023 C-Terminus 108100  (41048) 206200  (107110) 376600  (134870) 475600  (99316)
PF-05231023 N-Terminus 376100  (111420) 693400  (214250) 1508000  (253030) 2004000  (405880)
39.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose
Hide Description Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 21 21 21 21
Median (Full Range)
Unit of Measure: hours
PF-05231023 C-Terminus
0.5
(0.5 to 1.0)
0.5
(0.5 to 11.5)
0.5
(0.5 to 3.4)
0.5
(0.5 to 1.03)
PF-05231023 N-Terminus
1.0
(0.5 to 5.6)
1.0
(0.5 to 11.5)
1.0
(0.5 to 9.5)
1.0
(0.5 to 3.5)
40.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose
Hide Description Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 21 21 21 21
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
PF-05231023 C-Terminus 7983  (2000) 15250  (3672) 32980  (7944) 48320  (8376)
PF-05231023 N-Terminus 8881  (1743) 16800  (4740) 31750  (5134) 44470  (8516)
41.Secondary Outcome
Title Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose
Hide Description AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 18 15 19
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
PF-05231023 C-Terminus 76520  (26169) 136200  (34051) 301200  (71897) 424700  (97424)
PF-05231023 N-Terminus 467700  (136600) 855500  (269920) 1860000  (434690) 2326000  (433010)
42.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose
Hide Description Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 20 18 16 19
Median (Full Range)
Unit of Measure: hours
PF-05231023 C-Terminus
0.55
(0.50 to 1.02)
0.53
(0.45 to 1.00)
0.79
(0.48 to 3.50)
1.00
(0.50 to 1.00)
PF-05231023 N-Terminus
1.00
(0.50 to 4.55)
1.00
(0.48 to 4.50)
1.00
(0.50 to 4.50)
1.00
(0.50 to 4.52)
43.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose
Hide Description Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 20 18 16 19
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
PF-05231023 C-Terminus 7697  (1622) 14450  (3428) 29610  (5300) 42260  (7419)
PF-05231023 N-Terminus 9981  (3406) 16900  (3279) 33140  (9119) 48090  (17688)
44.Secondary Outcome
Title Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023
Hide Description Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 18 15 19
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
PF-05231023 C-Terminus 0.70  (0.23) 0.65  (0.20) 0.79  (0.24) 0.90  (0.17)
PF-05231023 N-Terminus 1.24  (0.20) 1.28  (0.31) 1.25  (0.15) 1.16  (0.15)
45.Secondary Outcome
Title Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023
Hide Description Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 20 18 16 19
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
PF-05231023 C-Terminus 0.93  (0.12) 0.96  (0.20) 0.89  (0.23) 0.89  (0.22)
PF-05231023 N-Terminus 1.13  (0.27) 1.04  (0.17) 1.04  (0.33) 1.10  (0.74)
46.Secondary Outcome
Title Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose
Hide Description Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 20 18 16 19
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
PF-05231023 C-Terminus 0.0001000  (0.00000) 0.0001000  (0.00000) 0.0001000  (0.00000) 0.0001866  (3.2348)
PF-05231023 N-Terminus 768.3  (405.33) 1213  (585.54) 3293  (1287.0) 4182  (1646.7)
47.Secondary Outcome
Title Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose
Hide Description Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 18 15 19
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
PF-05231023 C-Terminus 455.8  (156.12) 810.7  (203.85) 1793  (426.65) 2529  (581.04)
PF-05231023 N-Terminus 2783  (812.93) 5091  (1605.8) 11060  (2593.9) 13840  (2574.9)
48.Secondary Outcome
Title Plasma Decay Half-Life (t1/2) of PF-05231023
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 18 15 19
Mean (Standard Deviation)
Unit of Measure: hours
PF-05231023 C-Terminus 7.6  (1.0) 7.4  (1.3) 7.4  (1.2) 8.6  (3.5)
PF-05231023 N-Terminus 121.6  (16.5) 119.3  (24.5) 114.8  (12.5) 114.6  (12.0)
49.Secondary Outcome
Title Apparent Clearance (CL) of PF-05231023
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Time Frame 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.
Arm/Group Title PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description:
PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Overall Number of Participants Analyzed 19 18 15 19
Geometric Mean (Standard Deviation)
Unit of Measure: liter/hour (L/hr)
PF-05231023 C-Terminus 0.33  (0.09) 0.37  (0.08) 0.33  (0.09) 0.35  (0.08)
PF-05231023 N-Terminus 0.05  (0.02) 0.06  (0.02) 0.05  (0.01) 0.06  (0.01)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Hide Arm/Group Description Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4. PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
All-Cause Mortality
Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/22 (4.55%)   2/21 (9.52%)   0/21 (0.00%)   1/22 (4.55%)   0/21 (0.00%) 
Cardiac disorders           
Sinus tachycardia * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
General disorders           
Non-cardiac chest pain * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Immune system disorders           
Hypersensitivity * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Reproductive system and breast disorders           
Breast mass * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Pulmonary embolism * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo PF-05231023 25 mg PF-05231023 50 mg PF-05231023 100 mg PF-05231023 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/22 (50.00%)   15/21 (71.43%)   10/21 (47.62%)   12/22 (54.55%)   12/21 (57.14%) 
Blood and lymphatic system disorders           
Iron deficiency anaemia * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Cardiac disorders           
Tachycardia * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Eye disorders           
Ocular hyperaemia * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Gastrointestinal disorders           
Abdominal pain * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Abdominal pain lower * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Abdominal pain upper * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Diarrhoea * 1  0/22 (0.00%)  2/21 (9.52%)  1/21 (4.76%)  3/22 (13.64%)  8/21 (38.10%) 
Dyspepsia * 1  1/22 (4.55%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Flatulence * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Frequent bowel movements * 1  0/22 (0.00%)  1/21 (4.76%)  1/21 (4.76%)  3/22 (13.64%)  1/21 (4.76%) 
Nausea * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  2/22 (9.09%)  2/21 (9.52%) 
Toothache * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Vomiting * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  2/21 (9.52%) 
General disorders           
Chest pain * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Feeling cold * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Generalised oedema * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Hunger * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  2/21 (9.52%) 
Infusion site haematoma * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Oedema peripheral * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Vessel puncture site haemorrhage * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Infections and infestations           
Gastroenteritis * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Lower respiratory tract infection * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Rhinitis * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Upper respiratory tract infection * 1  0/22 (0.00%)  2/21 (9.52%)  0/21 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Viral infection * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Vulvovaginal mycotic infection * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications           
Ligament sprain * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Lower limb fracture * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Tooth fracture * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Investigations           
Alanine aminotransferase increased * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Aspartate aminotransferase increased * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Blood creatine phosphokinase increased * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Blood pressure diastolic increased * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Blood thyroid stimulating hormone increased * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Electrocardiogram ST segment abnormal * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Electrocardiogram T wave abnormal * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Neutrophil count increased * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
White blood cell count increased * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Gout * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  2/21 (9.52%) 
Hypoglycaemia * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Increased appetite * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Bursitis * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Flank pain * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Muscle spasms * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Muscle tightness * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Musculoskeletal pain * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Myalgia * 1  2/22 (9.09%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Pain in extremity * 1  1/22 (4.55%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Nervous system disorders           
Burning sensation * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Dizziness * 1  1/22 (4.55%)  2/21 (9.52%)  1/21 (4.76%)  1/22 (4.55%)  2/21 (9.52%) 
Dysgeusia * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Headache * 1  1/22 (4.55%)  1/21 (4.76%)  1/21 (4.76%)  1/22 (4.55%)  2/21 (9.52%) 
Paraesthesia * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  1/22 (4.55%)  1/21 (4.76%) 
Psychiatric disorders           
Anxiety * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Libido decreased * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Renal and urinary disorders           
Dysuria * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  1/21 (4.76%) 
Haematuria * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Reproductive system and breast disorders           
Erectile dysfunction * 1  1/22 (4.55%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Vaginal haemorrhage * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Oropharyngeal pain * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Sinus congestion * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Wheezing * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis contact * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Night sweats * 1  0/22 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/21 (0.00%) 
Pruritus * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
Rash * 1  0/22 (0.00%)  2/21 (9.52%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Rash erythematous * 1  0/22 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Rash papular * 1  1/22 (4.55%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/21 (0.00%) 
Vascular disorders           
Phlebitis * 1  0/22 (0.00%)  0/21 (0.00%)  1/21 (4.76%)  0/22 (0.00%)  0/21 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v16.0
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: NCT01673178    
Other Study ID Numbers: B2901011
First Submitted: August 22, 2012
First Posted: August 27, 2012
Results First Submitted: January 6, 2015
Results First Posted: January 14, 2015
Last Update Posted: February 16, 2015