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NCT04976855 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder
A Phase 1 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT04976855: Completed Phase 1 study, sponsored by Indivior.
NCT04976855 is a Phase 1 study that has completed, run by Indivior. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04976855, a Phase 1 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
The primary objectives for the study are: * Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers. * Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered alone and with SUBOXONE sublingual (SL) film in an opioid use disorder (OUD) treatment seeking population.
Interventions
- DRUG Placebo
- DRUG INDV-2000
- DRUG SUBOXONE® sublingual film
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2022-08-17 |
| Est. Completion | 2023-07-05 |
| Phase | Phase 1 |
What the finished NCT04976855 record still lists
NCT04976855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04976855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04976855 about?
NCT04976855 is a clinical study titled "Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder". The primary objectives for the study are: * Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers. * Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered alone and with SUBOXONE sublingual (SL) film in an opioid u...
What is the current status of trial NCT04976855?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2022-08-17. Estimated completion is 2023-07-05.
What interventions are being tested in trial NCT04976855?
The interventions under investigation include: Placebo (DRUG), INDV-2000 (DRUG), SUBOXONE® sublingual film (DRUG).
Who is sponsoring clinical trial NCT04976855?
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 NCT04976855's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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