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NCT03002961 · ClinicalTrials.gov registry record · Phase 1
Single Ascending Dose Study of RBP-6000
A Phase 1 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT03002961: Completed Phase 1 study, sponsored by Indivior.
NCT03002961 is a Phase 1 study that has completed, run by Indivior. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03002961, a Phase 1 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
A multi-center, open-label, single ascending dose study to enroll opioid dependent treatment-seeking subjects. Subjects to be enrolled into 3 cohorts receiving low, medium and high doses of depot buprenorphine. A fourth cohort will be enrolled to evaluate the PK of RBP-6000 after receiving suboxone tablets for 7 days.
Primary Outcome
Safety will be assessed by AEs, ECGs, laboratory measurements, local injection site tolerability and vital signs
Interventions
- DRUG RBP-6000
- DRUG Suboxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT03002961 record still lists
NCT03002961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which RBP-6000 is the first listed.
NCT03002961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03002961 about?
NCT03002961 is a clinical study titled "Single Ascending Dose Study of RBP-6000". A multi-center, open-label, single ascending dose study to enroll opioid dependent treatment-seeking subjects. Subjects to be enrolled into 3 cohorts receiving low, medium and high doses of depot buprenorphine. A fourth cohort will be enrolled to evaluate the PK of RBP-6000 after receiving suboxone ...
What is the current status of trial NCT03002961?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2012-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT03002961?
The interventions under investigation include: RBP-6000 (DRUG), Suboxone (DRUG).
Who is sponsoring clinical trial NCT03002961?
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 NCT03002961's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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