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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 is a Phase 1 study that has completed, run by Indivior. The registered enrollment target is 64 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04976855
The ClinicalTrials.gov registry entry for NCT04976855 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 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 Placebo is the first listed.
NCT04976855 reports 0 study locations.
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.
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