Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-06305591

Study type: Interventional

Funder types: Industry

Identifiers

NCT01747941

B5281001

Details and patient eligibility

About

The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy young subjects
• aged 18-55

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 the time of dosing).
• Pregnant or nursing females; females of childbearing potential.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Single ascending oral doses in fasted conditions

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-06305591

Drug: PF-06305591

Drug: PF-06305591

Cohort 2

Experimental group

Description:

Single ascending oral doses in fasted conditions

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-06305591

Drug: PF-06305591

Drug: PF-06305591

Cohort 3

Experimental group

Description:

Single ascending oral doses in fed conditions

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: PF-06305591

Drug: PF-06305591

Drug: PF-06305591