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NCT01366001 · ClinicalTrials.gov registry record · Phase 1
ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine
A Phase 1 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01366001: Completed Phase 1 study, sponsored by Alkermes.
NCT01366001 is a Phase 1 study that has completed, run by Alkermes. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366001, a Phase 1 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers.
Primary Outcome
For safety, the primary outcome measures are AEs and cardiovascular responses (Heart Rate, Blood Pressure, Electrocardiogram) collected during cocaine infusions at baseline and during treatment with ALKS 33-BUP, ALKS 33 and placebo.
Interventions
- DRUG Placebo
- DRUG ALKS 33-BUP
- DRUG ALKS 33
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT01366001 record still lists
NCT01366001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01366001 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01366001 about?
NCT01366001 is a clinical study titled "ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine". The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers.
What is the current status of trial NCT01366001?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2011-08. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01366001?
The interventions under investigation include: Placebo (DRUG), ALKS 33-BUP (DRUG), ALKS 33 (DRUG).
Who is sponsoring clinical trial NCT01366001?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01366001's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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