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

NCT ID: NCT02208284

Last Updated: 2015-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1-PF-06427878 or placebo

Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Placebo

Intervention Type DRUG

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Cohort 2-PF-06427878 or placebo

Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Placebo

Intervention Type DRUG

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Cohort 3-PF-06427878 or placebo

Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Placebo

Intervention Type DRUG

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Interventions

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PF-06427878

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Intervention Type DRUG

Placebo

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Intervention Type DRUG

PF-06427878

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Intervention Type DRUG

Placebo

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Intervention Type DRUG

PF-06427878

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Intervention Type DRUG

Placebo

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7871001&StudyName=A%20Single%20Oral%20Dose%20Study%20Of%20PF-06427878%20In%20Healthy%20Adult%20Subjects%20

To obtain contact information for a study center near you, click here.

Other Identifiers

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B7871001

Identifier Type: -

Identifier Source: org_study_id

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