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NCT06576843 · ClinicalTrials.gov registry record · Phase 2
INDV-6001 Multiple-Dose Pharmacokinetic Study
A Phase 2 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT06576843: Completed Phase 2 study, sponsored by Indivior.
NCT06576843 is a Phase 2 study that has completed, run by Indivior. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06576843, a Phase 2 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of INDV-6001 following multiple doses in participants with OUD to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal (TM) BUP (SUBOXONE®) or will transition from a 100-mg monthly maintenance dose of SC extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thigh, back of upper arm), which may be desirable in this patient population for the anticipated extended durations of treatment.
Primary Outcome
AUCtau for Cohorts 1-4
Interventions
- DRUG Sublocade
- DRUG Suboxone
- DRUG INDV-6001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2026-01-21 |
| Phase | Phase 2 |
What the finished NCT06576843 record still lists
NCT06576843 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Sublocade is the first listed.
NCT06576843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06576843 about?
NCT06576843 is a clinical study titled "INDV-6001 Multiple-Dose Pharmacokinetic Study". This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of ...
What is the current status of trial NCT06576843?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2024-09-17. Estimated completion is 2026-01-21.
What interventions are being tested in trial NCT06576843?
The interventions under investigation include: Sublocade (DRUG), Suboxone (DRUG), INDV-6001 (DRUG).
Who is sponsoring clinical trial NCT06576843?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06576843's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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