Study to Characterize the Pharmacokinetics of Raltegravir in the Gastrointestinal (GI) Tract of Healthy Male Volunteers

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to characterize the way the first commercially available integrase inhibitor, raltegravir, a new class of antiretrovirals that is used to treat HIV, is distributed into the rectal mucosal tissue. This information will generate important information regarding the drug's penetration into lymphoid tissues that are rapidly depleted in HIV infection. Subsequently strategies to prevent the sexual transmission of HIV and for treating HIV-infected individuals will be designed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Angela Kashuba, PharmD
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Raltegravir Potassium

Criteria

Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 49 years, inclusive, with intact genital tract and gastrointestinal tract. 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.

2. Body Mass Index (BMI) of approximately 18 to 30 kg/m^2; and a total body weight greater than or equal to 50 kg (110 lbs).

3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria

1) any medical condition or finding deemed by the investigators to be ineligible