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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821535
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : November 16, 2010
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare

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

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Infection Drug: maraviroc (Selzentry, Celsentri) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : February 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc

Arm Intervention/treatment
Active group
maraviroc dosing group
Drug: maraviroc (Selzentry, Celsentri)
12 subjects will receive a single dose of 300 mg maraviroc (two 150 mg maraviroc commercial tablets) under fasting conditions.
Other Name: Selzentry, Celsentri




Primary Outcome Measures :
  1. Plasma and urine maraviroc concentrations for pharmacokinetic analysis [ Time Frame: pre-48 hrs post dose ]
  2. Adverse event monitoring [ Time Frame: Day 0 to Day 3 ]
  3. Bood pressure, pulse rate [ Time Frame: Day 0, Day 1, and Day 3 ]
  4. Blood and urine safety laboratory tests [ Time Frame: Day 0 and Day 3 ]
  5. ECG [ Time Frame: Day 0 and Day 3 ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821535


Locations
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Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00821535    
Other Study ID Numbers: A4001084
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: November 2010
Keywords provided by ViiV Healthcare:
pharmacokinetics, Japanese, healthy volunteer, maraviroc
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Maraviroc
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
CCR5 Receptor Antagonists