Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Indivior. The registered enrollment target is 123 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06576843
The ClinicalTrials.gov registry entry for NCT06576843 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indivior, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sublocade is the first listed.
NCT06576843 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.