A Single Dose Study Of PF-06678552 In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06678552 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01992614

B7611001

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 single oral doses of PF-06678552 in healthy 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 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: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.

Treatment:

Drug: PF-06678552 or Placebo

Drug: PF-06678552 or Placebo

Drug: PF-06678552 or Placebo

Cohort 2

Experimental group

Description:

Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.

Treatment:

Drug: PF-06678552 or Placebo

Drug: PF-06678552 or Placebo

Drug: PF-06678552 or Placebo

Cohort 3

Experimental group

Description:

Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.

Treatment:

Drug: PF-06678552 or Placebo

Drug: PF-06678552 or Placebo

Drug: PF-06678552 or Placebo