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NCT04447287 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT04447287: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT04447287 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04447287, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062. This study also assessed the potential for pharmacokinetic interaction between ASP8062 and buprenorphine/naloxone.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. A treatment-emergent adverse ev
Interventions
- DRUG buprenorphine/naloxone
- DRUG ASP8062
- DRUG Placebo ASP8062
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2020-11-25 |
| Phase | Phase 1 |
What the finished NCT04447287 record still lists
NCT04447287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which buprenorphine/naloxone is the first listed.
NCT04447287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04447287 about?
NCT04447287 is a clinical study titled "A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder". The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062. This study also assessed the potential for pharmacokinetic interaction between ASP8062 and buprenorp...
What is the current status of trial NCT04447287?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-06-29. Estimated completion is 2020-11-25.
What interventions are being tested in trial NCT04447287?
The interventions under investigation include: buprenorphine/naloxone (DRUG), ASP8062 (DRUG), Placebo ASP8062 (DRUG).
Who is sponsoring clinical trial NCT04447287?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04447287's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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