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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

NCT01593046 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-02-10

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-11-30
Completion
2013-11-30

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 NCT01593046 on ClinicalTrials.gov