A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects

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NCT02208284

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Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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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.

- Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg

- Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast

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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Single Oral Dose Study Of PF-06427878 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-06427878 Co-administered With Meal In Healthy Adult Subjects
Brief Summary PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06427878 in healthy adult subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06427878
    PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
  • Drug: Placebo
    PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
Study Arms  ICMJE
  • Experimental: Cohort 1-PF-06427878 or placebo
    Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
    Interventions:
    • Drug: PF-06427878
    • Drug: Placebo
  • Experimental: Cohort 2-PF-06427878 or placebo
    Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
    Interventions:
    • Drug: PF-06427878
    • Drug: Placebo
  • Experimental: Cohort 3-PF-06427878 or placebo
    Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
    Interventions:
    • Drug: PF-06427878
    • Drug: 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: December 11, 2014)		16
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2014)		24
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
  • Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast

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).
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 NCT02208284
Other Study ID Numbers  ICMJE B7871001
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 CenterPfizer
PRS Account Pfizer
Verification Date March 2015

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