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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-06427878; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02855177

B7871005

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

PF-06427878

Experimental group

Description:

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

Treatment:

Drug: PF-06427878