A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-24

Study Completion Date

2017-04-12

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 after 2 weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo as suspension administered every 8 hours, with food

PF-06427878

PF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days

Group Type EXPERIMENTAL

PF-06427878

Intervention Type DRUG

500 mg suspension administered every 8 hours, with food

Interventions

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Placebo

Placebo as suspension administered every 8 hours, with food

Intervention Type DRUG

PF-06427878

500 mg suspension administered every 8 hours, with food

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 \>=25 kg/m2; and a total body weight \>50 kg
* Subjects with liver fat \>=6% and \<=20%

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