drugset / Trial / NCT00659191

A Healthy Volunteer And Patient Study To Assess The Safety, Tolerability And Pharmacokinetics Of GSK1265744

NCT00659191

Phase 1 Completed 58 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is a Phase I single and repeat dose escalation study of GSK1265744 in healthy subjects and a single repeat dose cohort in HIV-1 infected subjects. The study is planned to consist of three parts. Part A will enroll two cohorts with a total of 18 subjects in a single dose escalation to evaluate safety, tolerability and PK. Part B plans to enroll three cohorts of 10 subjects to evaluate repeat doses of GSK126744 on safety, tolerability and PK. Part A and B will enroll healthy volunteers. Part C will enroll HIV-1 patients in a single cohort of 10 subjects. This cohort will evaluate the effects of repeat dose on safety, tolerability, PK and efficacy.

Timeline

Start
2008-02
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabotegravir Small molecule