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Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers

NCT ID: NCT00821535

Last Updated: 2010-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-05-31

Brief Summary

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To confirm safety and pharmacokinetics of maraviroc following a single oral dose of 300 mg maraviroc in healthy male Japanese volunteers.

Detailed Description

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Conditions

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Human Immunodeficiency Virus (HIV) Infection

Keywords

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pharmacokinetics, Japanese, healthy volunteer, maraviroc

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Active group

maraviroc dosing group

Group Type OTHER

maraviroc (Selzentry, Celsentri)

Intervention Type DRUG

12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.

Interventions

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maraviroc (Selzentry, Celsentri)

12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.

Intervention Type DRUG

Other Intervention Names

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Selzentry, Celsentri

Eligibility Criteria

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Inclusion Criteria

* Healthy male Japanese subjects between the ages of 21 and 50 years inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg.

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).
* Positive result for HIV, Hepatitis B surface antigen (HbsAg) or HCV antibody.
* Hypersensitivity/allergic reactions to any component of maraviroc, including soy lecithin.
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001084&StudyName=Investigation%20Of%20Safety%20And%20Pharmacokinetics%20Following%20A%20Single%20Oral%20Dose%20Of%20300%20Mg%20Maraviroc%20In%20Healthy%20Male%20Japanese%20Volunteers

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

Other Identifiers

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A4001084

Identifier Type: -

Identifier Source: org_study_id