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NCT04371380 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04371380: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT04371380 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04371380, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir and rilpivirine in plasma following the administration of a single 600 milligram (mg) and a 900 mg intramuscular (IM) injection respectively, to separate vastus lateralis muscles on each leg. Cabotegravir is an integrase inhibitor being developed in combination with rilpivirine, a non-nucleoside reverse transcriptase inhibitor, for the treatment of human immunodeficiency virus (HIV). The objective is to evaluate pharmacokinetics, tolerability, and safety of cabotegravir long acting plus rilpivirine long acting administered concomitantly as two separate IM injections in the vastus lateralis muscle of adult healthy participants. The screening phase will be of 30 days, oral lead-in (OLI) phase of 28 days, there will be washout period of 10-14 days, followed by an injection phase and follow-up period will be up to 52-weeks. Approximately 15 adult healthy participants will be enrolled.
Primary Outcome
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB.
Interventions
- DRUG Cabotegravir Tablets
- DRUG Rilpivirine Tablets
- DRUG Cabotegravir extended release suspension for injection (long-acting)
- DRUG Rilpivirine extended release suspension for injection (long-acting)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2021-12-26 |
| Phase | Phase 1 |
What the finished NCT04371380 record still lists
NCT04371380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Cabotegravir Tablets is the first listed.
NCT04371380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04371380 about?
NCT04371380 is a clinical study titled "Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants". This is a phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir and rilpivirine in plasma following the administration of a single 600 milligram (mg) and a 900 mg intramuscular (IM) injection respectively, to separate vastus lateralis muscles on each leg. C...
What is the current status of trial NCT04371380?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2020-09-16. Estimated completion is 2021-12-26.
What interventions are being tested in trial NCT04371380?
The interventions under investigation include: Cabotegravir Tablets (DRUG), Rilpivirine Tablets (DRUG), Cabotegravir extended release suspension for injection (long-acting) (DRUG), Rilpivirine extended release suspension for injection (long-acting) (DRUG).
Who is sponsoring clinical trial NCT04371380?
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 NCT04371380's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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
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