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

NCT ID: NCT01250730

Last Updated: 2011-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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PK profile in Japanese healthy male volunteers

Study Design

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Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1.0

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).

Group Type EXPERIMENTAL

PF-02341066

Intervention Type DRUG

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

PF-02341066

Intervention Type DRUG

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

PF-02341066

Intervention Type DRUG

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

Interventions

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PF-02341066

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

Intervention Type DRUG

PF-02341066

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

Intervention Type DRUG

PF-02341066

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hachioji-shi, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081022&StudyName=A%20Study%20In%20Japanese%20Healthy%20Male%20Volunteers%20To%20Investigate%20The%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20Of%20PF-02341066%20

To obtain contact information for a study center near you, click here.

Other Identifiers

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A8081022

Identifier Type: -

Identifier Source: org_study_id