A Multiple Dose Study Of PF-06678552 In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-06678552

Study type: Interventional

Funder types: Industry

Identifiers

NCT02079922

B7611002

Details and patient eligibility

About

PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of PF-06678552 in healthy subjects.

Enrollment: 38 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 18 to 30.5 kg/m2; and a total body weight >50 kg
• Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

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: Triple Blind

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38 participants in 6 patient groups

Cohort 1

Experimental group

Description:

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Cohort 2

Experimental group

Description:

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Cohort 3

Experimental group

Description:

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Cohort 4

Experimental group

Description:

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Cohort 5

Experimental group

Description:

Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Cohort 6

Experimental group

Description:

Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: PF-06678552

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-06678552

Drug: PF-06678552