Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT01593046 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01593046 record still lists
NCT01593046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 5 interventions - of which GSK1265744 Oral is the first listed.
NCT01593046 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01593046's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03726359 · 43 participants · Phase 1
Phase I Study of Fractionated Stereotactic Radiation Therapy
- NCT03850418 · 43 participants · Phase 2
Azacitidine and Chimerism in MDS or AML Patients After Allogeneic Stem Cell Transplant
- NCT04144023 · 43 participants · Phase 1
A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ
- NCT04176718 · 43 participants · Phase 2
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia