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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06427878; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02208284

B7871001

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 of single oral doses of PF-06427878 in healthy adult subjects.

Enrollment: 16 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 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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 3 patient groups

Cohort 1-PF-06427878 or placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-06427878

Drug: PF-06427878

Drug: PF-06427878

Drug: Placebo

Drug: Placebo

Cohort 2-PF-06427878 or placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-06427878

Drug: PF-06427878

Drug: PF-06427878

Drug: Placebo

Drug: Placebo

Cohort 3-PF-06427878 or placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-06427878

Drug: PF-06427878

Drug: PF-06427878

Drug: Placebo

Drug: Placebo