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Investigation Of Safety And Pharmacokinetics Following A Single Oral Dose Of 300 Mg Maraviroc In Healthy Male Japanese Volunteers | Clinical Trials | Clareo Health

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

An Open Label Single Dose Study To Investigate Safety And Pharmacokinetics Of Maraviroc Following A Single Oral Dose Of 300 Mg Maraviroc (Two 150 Mg Maraviroc Commercial Tablets) Under Fasting Conditions In Healthy Male Japanese Volunteers

NCT00821535•ViiV Healthcare

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

21 - 50 years

Sex

MALE

Healthy Volunteers

Yes

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.

Locations (1)

Pfizer Investigational Site

Singapore, Singapore

Key Dates

Start Date

February 1, 2009

Primary Completion Date

May 1, 2009

Completion Date

May 1, 2009

Last Updated

November 16, 2010

Enrollment

ACTUAL participants

Conditions

Human Immunodeficiency Virus (HIV) Infection

Interventions

maraviroc (Selzentry, Celsentri)

DRUG

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

NCT04375800

Human Immunodeficiency Virus (HIV) Infection

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RECRUITINGNA

Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India

NCT07209917

Cervical CancerHuman Papillomavirus (HPV) Infection+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India

Strategies to AchieVe Viral Suppression for Youth With HIV

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A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment