First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects

NCT03309241

Last updated date
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Contact
1-800-254-6398

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
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 female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
  • - Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • - Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

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 (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the 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 IP (whichever is longer).
  • - Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
  • - Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose

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Advanced Information
Descriptive Information
Brief Title  ICMJE First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06882961 In Healthy Adult Subjects
Brief Summary The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study of PF-06882961.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind (sponsor open)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: PF-06882961
    Single Ascending Doses of PF-06882961 from 3mg to TBD mg.
  • Other: Placebo
    Placebo Single Dose
Study Arms  ICMJE
  • Experimental: Cohort 1
    Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject.
    Interventions:
    • Drug: PF-06882961
    • Other: Placebo
  • Experimental: Cohort 2
    Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject.
    Interventions:
    • Drug: PF-06882961
    • Other: Placebo
  • Experimental: Cohort 3 (optional)
    Single Ascending Dose administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject.
    Interventions:
    • Drug: PF-06882961
    • Other: Placebo
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: March 30, 2018)
25
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2017)
24
Actual Study Completion Date  ICMJE March 22, 2018
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
  • Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the 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 IP (whichever is longer).
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose
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 NCT03309241
Other Study ID Numbers  ICMJE C3421001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2018

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