A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: PF-06427878

Study type: Interventional

Funder types: Industry

Identifiers

NCT02391623

B7871002

2015-000130-29 (EudraCT Number)

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

Enrollment: 40 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
• Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 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

40 participants in 6 patient groups

Cohort 1

Experimental group

Description:

Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: PF-06427878

Drug: PF-06427878

Drug: Placebo

Cohort 2

Experimental group

Description:

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: PF-06427878

Drug: PF-06427878

Drug: Placebo

Cohort 3

Experimental group

Description:

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: PF-06427878

Drug: PF-06427878

Drug: Placebo

Cohort 4

Experimental group

Description:

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: PF-06427878

Drug: PF-06427878

Drug: Placebo

Cohort 5

Experimental group

Description:

Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: PF-06427878

Drug: PF-06427878

Drug: Placebo

Cohort 6

Experimental group

Description:

Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: PF-06427878

Drug: PF-06427878

Drug: Placebo