NCT01593046

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects

A Randomized, Open Label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety, tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a long acting parenteral (LAP) formulation in healthy subjects. Subjects will be randomized to 3 monthly dosing cohorts and 1 quarterly dosing cohort with either intramuscular or subcutaneous dosing. In the monthly dosing cohorts subjects will receive GSK1265744 alone for 2 months and then in combination with TMC278 long acting parenteral (LA) for 2 months. For the quarterly dosing cohort, 2 quarterly intramuscular doses of GSK1265744 LAP will be given alone. Three dose levels of GSK1265744 will be evaluated partly in combination with TMC278 LA to adequately characterize the GSK1265744 LAP and TMC278 LA safety, tolerability, and PK profile. A total enrolment of approximately 40 healthy subjects is planned for this study.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GSK1265744 Oral	30mg tablet
DRUG	GSK1265744 LAP 800mg intramuscular injection	800mg Loading dose given at month 1 dose
DRUG	GSK1265744 LAP 200mg subcutaneous injection	200mg maintenance dose give at months 2 - 4
DRUG	GSK1265744 LAP 200mg intramuscular injection	200mg maintenance dose given at months 2 - 4
DRUG	GSK1265744 LAP 400mg intramuscular injection	400mg maintenance dose given at month 2 - 4
DRUG	TMC278 LA 1200mg intramuscular injection	1200mg Loading dose given at month 3
DRUG	TMC278 LA 600mg intramuscular injection	600mg Loading dose given at month 4
DRUG	GSK1265744 LAP 800mg intramuscular injection	800mg dose given quarterly (once every) 12 weeks

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-05-07
• Last updated: 2014-02-10

Locations

2 sites across 1 country: United States