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NCT01593046 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01593046 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 43 participants.
The verdict
NCT01593046, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
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.
Interventions
- DRUG GSK1265744 Oral
- DRUG GSK1265744 LAP 800mg intramuscular injection
- DRUG GSK1265744 LAP 200mg subcutaneous injection
- DRUG GSK1265744 LAP 200mg intramuscular injection
- DRUG GSK1265744 LAP 400mg intramuscular injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01593046
The ClinicalTrials.gov registry entry for NCT01593046 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which GSK1265744 Oral is the first listed.
NCT01593046 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01593046 about?
NCT01593046 is a clinical study titled "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". 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...
What is the current status of trial NCT01593046?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2012-05. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01593046?
The interventions under investigation include: GSK1265744 Oral (DRUG), GSK1265744 LAP 800mg intramuscular injection (DRUG), GSK1265744 LAP 200mg subcutaneous injection (DRUG), GSK1265744 LAP 200mg intramuscular injection (DRUG), GSK1265744 LAP 400mg intramuscular injection (DRUG).
Who is sponsoring clinical trial NCT01593046?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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