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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

Last updated on November 19, 2019

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Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02184429
Pfizer
Completed
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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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 SummaryThis 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 DescriptionNot 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 DateMarch 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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