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

Pfizer24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

PlaceboDRUG

Placebo as suspension administered every 8 hours, with food

PF-06427878DRUG

500 mg suspension administered every 8 hours, with food

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (2)

California Clinical Trials Medical Group

Glendale, California, United States

Qps-Mra, Llc

South Miami, Florida, United States

Outcomes

Primary Outcomes

Number of Treatment Emergent Treatment-Related Adverse Events (AEs)

Time frame: Day -2 to Day 44

Change from baseline in clinical laboratory tests

Time frame: Day 1 to Day 22

Change from baseline in vital signs

Time frame: Day 0 to Day 22

Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram

Time frame: Day 0 to Day 22