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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 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04447287
The ClinicalTrials.gov registry entry for NCT04447287 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which buprenorphine/naloxone is the first listed.
NCT04447287 reports 0 study locations.
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.
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