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

Human Immunodeficiency Virus (HIV) Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821535
• Other study ID #: A4001084
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2009
• Last updated: November 15, 2010
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: November 2010
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: The Health Sciences Authority (HSA) Singapore
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV) Infection
• Immunologic Deficiency Syndromes

Intervention

Drug:
• maraviroc (Selzentry, Celsentri)
12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma and urine maraviroc concentrations for pharmacokinetic analysis		pre-48 hrs post dose	Yes
Primary	Adverse event monitoring		Day 0 to Day 3	No
Primary	Bood pressure, pulse rate		Day 0, Day 1, and Day 3	No
Primary	Blood and urine safety laboratory tests		Day 0 and Day 3	Yes
Primary	ECG		Day 0 and Day 3	No

External Links

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