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Trial record 1 of 1 for:    NCT02565628
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PF-06669571 In Subjects With Idiopathic Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02565628
Recruitment Status : Completed
First Posted : October 1, 2015
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE October 1, 2015
Results First Submitted Date  ICMJE April 25, 2017
Results First Posted Date  ICMJE August 7, 2017
Last Update Posted Date August 7, 2017
Actual Study Start Date  ICMJE November 16, 2015
Actual Primary Completion Date May 13, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Day 7. [ Time Frame: Day 7 ]
    The total MDS-UPDRS score is the most common method of evaluating the severity of Parkinson's disease across behaviors, activities of daily living, motor abilities, and other complications of Parkinson's disease. The MDS-UPDRS focuses primarily on measuring impairments associated with Parkinson's disease, with subsections organized according to motor and non-motor aspects of the disease. Part III assesses the motor signs of Parkinson's disease. Higher total scores indicate more severe motor signs of Parkinson's disease. Negative changes from baseline indicate improvement. MDS-UPDRS Part III total motor score is comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate and 4 = severe.
  • Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category by Study Visit on Day -2, Day 8 or Early Withdrawal, and Early Withdrawal/Follow-Up Visit [ Time Frame: Day -2, Day 8, and follow-up visit (Day 7 - 14 after last dose of PF-06669571) ]
    The number of participants in each C-CASA category was mapped from Columbia-Suicide Severity Rating Scale (C-SSRS) data. C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("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 or some intent to act, with specific plan and intent"), any suicidal behavior or ideation, self-injurious behavior (7) ("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
  • Number of Participants With New Onset and Worsening of Post-Baseline Suicidality. [ Time Frame: Day 8 or follow-up visit (Day 7 - 14 after last dose of PF-06669571) ]
    Number of participants with new onset and worsening of post-baseline suicidality was reported
  • Number of Participants With Treatment Emergent Adverse Events (All Causalities) [ Time Frame: Day 1 to 28 calendar days after the last dose of investigational product ]
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
  • Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values) [ Time Frame: Screening, Days -1, 1, 7 and 8, and follow-up visit ]
    Number of participants with supine and standing vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for supine/standing systolic blood pressure (SBP), supine/standing diastolic blood pressure (DBP), and supine/standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: (1) absolute supine SBP <90 millimeters of mercury (mmHg); (2) absolute standing SBP <90 mmHg; (3)absolute supine DBP<50mmHg; (4)absolute standing DBP<50mmHg (5) absolute supine pulse rate <40 beats per minute (bpm); (6) absolute supine pulse rate >120 bpm;(7) absolute standing pulse rate <40 bpm; (8) absolute standing pulse rate >140 bpm.
  • Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline) [ Time Frame: Screening, Days -1, 1, 7 and 8, and follow-up visit ]
    The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine systolic BP (SBP) >=30 millimeters of mercury (mmHg); Criterion B maximum increase from baseline in standing SBP >=30 mmHg; Criterion C: maximum increase from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum increase from baseline in standing diastolic BP(DBP) >=20 mmHg
  • Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline) [ Time Frame: Screening, Days -1, 1, 7 and 8, and follow-up visit ]
    The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine systolic BP (SBP) >=30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >=30 mmHg; Criterion C: maximum decrease from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum decrease from baseline in standing diastolic BP(DBP) >=20 mmHg
  • Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value) [ Time Frame: Screening, Days 1, 7, and 8, and follow-up visit ]
    The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRs complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) >=500 msec
  • Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline) [ Time Frame: Screening, Days 1, 7, and 8, and follow-up visit ]
    Number of participants with ECG(standard 12-lead) meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>=25/50%; Criterion B: maximum QRs complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval increase from baseline change >=60 msec.
  • Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality) [ Time Frame: Screening, Days 1, 4, and 7, and follow-up visit ]
    Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),liver function(total bilirubin, direct bilirubin, aspartate, aspartate aminotransferase, alanine, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose) ,and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, qualitative ketones, qualitative bilirubin, nitrites, leukocyte esterase, urine urobilinogen, urine leukocyte, esterase and microscopy).
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Maximum percent change from baseline in Movement Disorder Society-sponsor revision of the Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III at Day 7. [ Time Frame: Baseline, Day 7 ]
  • Number of participants with catergorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Day -2 ]
    C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("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 or some intent to act, without specific plan and intent"), any suicidal behavior or ideation, self-injurious behavior (7) ("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
  • Number of participants with catergorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Day 8 ]
    C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("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 or some intent to act, without specific plan and intent"), any suicidal behavior or ideation, self-injurious behavior (7) ("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
  • Number of participants with catergorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Follow-up (Day 7 - 14 after last dose of PF-06669571) ]
    C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("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 or some intent to act, without specific plan and intent"), any suicidal behavior or ideation, self-injurious behavior (7) ("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7 [ Time Frame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7 ]
    Cmax of PF-06669671 was observed directly from data on Day 1 and Day 7
  • Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7 [ Time Frame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7 ]
    AUC12 of PF-06669571 refers to the area under the curve from time zero to 12 hours post dose on Day 1 and Day 7. AUC12 was determined by using linear/log trapezoidal method.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7 [ Time Frame: 0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7 ]
    Tmax of PF-06669571 was observed directly from data on Day 1 and Day 7, as time of first occurrence.
  • Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7 [ Time Frame: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7 ]
    AUC24 of PF-06669571 refers to the area under the curve from time zero to 24 hours post dose on Day 7. AUC24 was determined by using linear/log trapezoidal method
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Single dose maximum observed plasma concentration (Cmax) of PF-06669571 [ Time Frame: 0, 1, 3, 5, 8 and 12 hours post-dose on Day 1 ]
  • Multiple dose maximum observed plasma concentration (Cmax) of PF-06669571 [ Time Frame: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7 ]
  • Single dose area under curve from time zero to 12 hours (AUC12) of PF-06669571 [ Time Frame: 0, 1, 3, 5, 8 and 12 hours post-dose on Day 1 ]
  • Multiple dose area under curve from time zero to 24 hours (AUC24) of PF-06669571 [ Time Frame: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7 ]
  • Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06669571 [ Time Frame: 0, 1, 3, 5, 8 and 12 hours post-dose on Day 1 ]
  • Multiple dose time to reach maximum observed plasma concentration (Tmax) of PF-06669571 [ Time Frame: 0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 1 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PF-06669571 In Subjects With Idiopathic Parkinson's Disease
Official Title  ICMJE A Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.
Brief Summary This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Idiopathic Parkinson's Disease
Intervention  ICMJE
  • Drug: PF-06669571
    1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: PF-06669571
    Once daily (QD) for 7 days
    Intervention: Drug: PF-06669571
  • Placebo Comparator: Placebo
    QD for 7 days
    Intervention: Drug: Placebo
Publications * Gurrell R, Duvvuri S, Sun P, DeMartinis N. A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. Clin Drug Investig. 2018 Jun;38(6):509-517. doi: 10.1007/s40261-018-0632-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2016)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2015)
19
Actual Study Completion Date  ICMJE May 13, 2016
Actual Primary Completion Date May 13, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
  • Must be Hoehn & Yahr Stage II-III inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia.
  • Subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of Parkinson's disease medication. Subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome.

Exclusion Criteria:

- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02565628
Other Study ID Numbers  ICMJE B7821002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP