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NCT01754116 · ClinicalTrials.gov registry record · Phase 1
A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01754116 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 43 participants.
The verdict
NCT01754116, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This study will evaluate LAP formulations of GSK1265744 with different particle sizes. Following a 14 day lead in period with oral GSK1265744, forty-five subjects will receive 400 mg of one of three GSK1265744 formulations which vary in particle size from 200 nm to 5 um by intramuscular injection. Samples for determination of GSK1265744 concentrations will be collected for 12 weeks post-injection. Safety will be evaluated by adverse event recording and laboratory values at frequent intervals throughout the trial. A subgroup of 12 subjects will receive a 3 mg dose of oral midazolam at baseline on Day-29 and then again on the last day of the oral GSK1265744 lead in period to evaluate the effect of GSK1265744 on CYP3A enzymes. The subjects will undergo follow-up evaluations for a minimum of 12 weeks.
Interventions
- DRUG GSK1265744 30 mg oral
- DRUG Midazolam 3 mg oral + GSK1265744 30mg oral
- DRUG GSK1265744 400 mg (200 nm)
- DRUG GSK1265744 400 mg (1 micro m)
- DRUG GSK1265744 400 mg (5 micro m)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01754116
The ClinicalTrials.gov registry entry for NCT01754116 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 30 mg oral is the first listed.
NCT01754116 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01754116 about?
NCT01754116 is a clinical study titled "A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects". This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This study will evaluate LAP ...
What is the current status of trial NCT01754116?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2013-01. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01754116?
The interventions under investigation include: GSK1265744 30 mg oral (DRUG), Midazolam 3 mg oral + GSK1265744 30mg oral (DRUG), GSK1265744 400 mg (200 nm) (DRUG), GSK1265744 400 mg (1 micro m) (DRUG), GSK1265744 400 mg (5 micro m) (DRUG).
Who is sponsoring clinical trial NCT01754116?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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