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

NCT01325051 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-01-05

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Raltegravir

400 mg tablets by mouth BID from Day 1 - Day 7 after enrollment visit

Sponsors & Collaborators

Principal Investigators

  • Angela Kashuba, PharmD · UNC-CH School of Pharmacy

  • Kristine Patterson, MD · UNC-CH Division of Infectious Diseases

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01325051 on ClinicalTrials.gov