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NCT02799264 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of High Fat Meal on Cabotegravir
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02799264 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 24 participants.
The verdict
NCT02799264, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1 infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen (post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food for optimal absorption; therefore the recommended intake of cabotegravir in the planned Phase 3 treatment studies is with food regardless of fat or calorie content, when administered along with rilpivirine. This is a single-center, randomized, open-label, two-way crossover study in healthy adult subjects to assess the effect of a high fat meal on the single dose pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled in the study and will be screened for 30 days. Twelve subjects with at least 10 hours of fasting will be randomized to receive a single dose of cabotegravir orally (Schedule 'A'). The remaining 12 subjects will receive a single dose of cabotegravir orally along with high fat meal (Schedule 'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be switched to 'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All the subjects will be followed up to 30 days from the day of receiving first dose of cabotegravir to evaluate the effect of a high fat meal on the pharmacokinetics of cabotegravir.
Interventions
- DRUG Cabotegravir 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-06 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02799264
The ClinicalTrials.gov registry entry for NCT02799264 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 1 intervention - of which Cabotegravir 30 mg is the first listed.
NCT02799264 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02799264 about?
NCT02799264 is a clinical study titled "A Study to Evaluate the Effect of High Fat Meal on Cabotegravir". Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1 infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen (post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food for optimal absorption; t...
What is the current status of trial NCT02799264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-06. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02799264?
The interventions under investigation include: Cabotegravir 30 mg (DRUG).
Who is sponsoring clinical trial NCT02799264?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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