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Trial record 1 of 1 for:    NCT02184429
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A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions

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ClinicalTrials.gov Identifier: NCT02184429
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 3, 2014
First Posted Date  ICMJE July 9, 2014
Last Update Posted Date September 6, 2018
Study Start Date  ICMJE July 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: screening,Day 28 ]
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, without specific plan or 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").
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2014)
  • Maximum Observed Plasma Concentration (Cmax) after single dose [ Time Frame: 0-Day 5 ]
    Cmax after a single dose
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose [ Time Frame: 0-Day 5 ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose [ Time Frame: 0-Day 5 ]
    AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose [ Time Frame: 0-Day 5 ]
    Tmax after single dose
  • Plasma Decay Half-Life (t1/2) after single dose [ Time Frame: 0-Day 5 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose
  • Apparent Oral Clearance (CL/F) after single dose [ Time Frame: 0-Day 5 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood after single dose
  • Apparent Volume of Distribution (Vz/F) after single dose [ Time Frame: 0-Day 5 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
  • Maximum Observed Plasma Concentration (Cmax) on Days 1, 7 and 14 after multiple daily dose [ Time Frame: 0-Day 18 ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on days 1,7,14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) on days 1,7 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Apparent Oral Clearance (CL/F) on day 7 and 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
  • Pre dose concentrations (Ctrough) on days 7 and 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Minimum Observed Plasma Trough Concentration (Cmin) on days 7 and 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Accumulation ratio (Rac) for AUCtau on days 7 and 14 after multiple daily doses [ Time Frame: 0-day 18 ]
  • Accumulation ratio (Rac) for Cmax on days 7 and 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Plasma Decay Half-Life (t1/2) on day 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Apparent Volume of Distribution (Vz/F) on day 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
  • Renal clearance (CLr) on day 14 [ Time Frame: 0-Day 18 ]
  • Amount of unchanged drug recovered in urine during the dosing interval (AEtau) on Day 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Percent of dose recovered unchanged in urine during the dosing interval (AEtau%) on Day 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Peak to Trough ratio at Steady State (PTR) [ Time Frame: 0-Day 18 ]
    Cmax to Cmin ratio at steady state
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
  • Maximum Observed Plasma Concentration (Cmax) after single dose [ Time Frame: 0-Day 5 ]
    Cmax after a single dose
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose [ Time Frame: 0-Day 5 ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose [ Time Frame: 0-Day 5 ]
    AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose [ Time Frame: 0-Day 5 ]
    Tmax after single dose
  • Plasma Decay Half-Life (t1/2) after single dose [ Time Frame: 0-Day 5 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose
  • Apparent Oral Clearance (CL/F) after single dose [ Time Frame: 0-Day 5 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood after single dose
  • Apparent Volume of Distribution (Vz/F) after single dose [ Time Frame: 0-Day 5 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
  • Maximum Observed Plasma Concentration (Cmax) on Days 1, 7 and 14 after multiple daily dose [ Time Frame: 0-Day 18 ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on days 1,7,14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) on days 1,7 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Apparent Oral Clearance (CL/F) on day 7 and 14 aftrer multiple daily doses [ Time Frame: 0-Day 18 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
  • Pre dose concentrations (Ctrough) on days 7 and 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Minimum Observed Plasma Trough Concentration (Cmin) on days 7 and 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Accumulation ratio (Rac) for AUCtau on days 7 and 14 after multiple daily doses [ Time Frame: 0-day 18 ]
  • Accumulation ratio (Rac) for Cmax on days 7 and 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Plasma Decay Half-Life (t1/2) on day 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Apparent Volume of Distribution (Vz/F) on day 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
  • Renal clearance (CLr) on day 14 [ Time Frame: 0-Day 18 ]
  • Amount of unchanged drug recovered in urine during the dosing interval (AEtau) on Day 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
  • Percent of dose recovered unchanged in urine during the dosing interval (AEtau%) on Day 14 after multiple daily doses [ Time Frame: 0-Day 18 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions
Official Title  ICMJE A Phase 1, Double Blind, Sponsor Open, Placebo Controlled Combined Single And Multiple Ascending Dose Study To Investigate The Safety, Tolerability And Food Effect On Pharmacokinetics Of PF-06669571 Following Oral Doses In Healthy Subjects
Brief Summary This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of food on PF-06669571 plasma concentrations will be be evaluated after a single dose of PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days
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 Healthy
Intervention  ICMJE
  • Drug: PF-06669571
    Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
  • Drug: PF-06669571
    Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
  • Drug: PF-06669571
    Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
  • Drug: PF-06669571
    Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
  • Drug: PF-06669571
    Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme
  • Drug: PF-06669571
    Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme
  • Drug: PF-06669571
    Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days. This dose may be reached by a titration scheme
Study Arms  ICMJE
  • Experimental: Single Ascending Dose-1
    Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design
    Intervention: Drug: PF-06669571
  • Experimental: Single Ascending Dose-2
    Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design
    Intervention: Drug: PF-06669571
  • Experimental: Multiple Ascending Dose-1
    Daily dose of PF-06669571 in healthy volunteers
    Intervention: Drug: PF-06669571
  • Experimental: Multiple Ascending Dose-2
    Daily dose of PF-06669571 in healthy volunteers
    Intervention: Drug: PF-06669571
  • Experimental: Multiple Ascending Dose-3
    Daily dose of PF-06669571 in healthy volunteers
    Intervention: Drug: PF-06669571
  • Experimental: Multiple Ascending Dose-4
    Daily dose of PF-06669571 in healthy volunteers
    Intervention: Drug: PF-06669571
  • Experimental: Multiple Ascending Dose-5
    Daily dose of PF-06669571 in healthy volunteers
    Intervention: Drug: PF-06669571
Publications * Not Provided

*   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: April 16, 2015)
56
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2014)
66
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Female subjects of non-childbearing potential must meet at least one of the following criteria:

  1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
  2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.

    • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
    • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
  • Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), repeat per local standard operating procedures (SOP). If orthostatic changes are present and deemed to be clinically significant by the investigator, Subject can be excluded.
  • For subjects who answer "Yes" to the Columbia Suicide Severity Rating Scale (C-SSRS) questions 4 or 5, a risk assessment should be done by a qualified mental health professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to assess whether it is safe for the subject to participate in the study. In addition, subjects deemed by the investigator to be at significant risk of suicidal or violent behavior should be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02184429
Other Study ID Numbers  ICMJE B7821001
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 March 2016

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