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

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NCT02208284

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 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).

NCT02208284
Pfizer
Completed
A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects

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[email protected]

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A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2014
December 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02208284
B7871001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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