drugset / Trial / NCT01756131

A Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects

NCT01756131

Phase 1 Completed 72 enrolled ViiV Healthcare GlaxoSmithKline · collab
RandomizedSingle-groupSingle-blind

Summary

A single dose escalation study to determine the safety, tolerability, and pharmacokinetic profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and follow-up evaluations for a minimum of 12 weeks following the injection.

Timeline

Start
2010-09
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabotegravir Small molecule 100 mg Intramuscular
Subject Cabotegravir Small molecule 200 mg Intramuscular
Subject Cabotegravir Small molecule 400 mg Intramuscular
Subject Cabotegravir Small molecule 800 mg Intramuscular