A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-02341066

Study type: Interventional

Funder types: Industry

Identifiers

NCT01250730

A8081022

Details and patient eligibility

About

The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.

Full description

The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.

Enrollment: 18 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion criteria

• Subjects who are smoking,
• Subjects with evidence of disease,
• Subjects with conditions affecting absorption,
• Subjects with treatment with other investigational drug within 30 days,
• Subjects with history of regular alcohol consumption,
• Subjects with use of prescription, nonprescription drugs and dietary supplement within 28 days,
• Subjects with blood donation of approximately 400 mL within 3 months or 200 mL within 1 month prior to dosing

Trial design

18 participants in 1 patient group

1.0

Experimental group

Description:

This study will consist of three cohorts: PF-02341066 150 mg treatment group (n = 6), PF-02341066 250 mg treatment group (n = 6) and PF-02341066 400 mg treatment group (n = 6).

Treatment:

Drug: PF-02341066

Drug: PF-02341066

Drug: PF-02341066