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

Pfizer18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PF-02341066DRUG

Cohort 1: a 150 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 1 x 100 mg IRT.

PF-02341066DRUG

Cohort 2: a 250 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 2 x 100 mg IRTs.

PF-02341066DRUG

Cohort 3: a 400 mg single dose of PF-02341066 administered as 4 x 100 mg IRTs.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Hachioji-shi, Tokyo, Japan

Outcomes

Primary Outcomes

Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] of Crizotinib

AUC(0-inf) of crizotinib is estimated from the crizotinib concentration. It is obtained from AUClast plus (Clast/kel). AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration. Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant.