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NCT04448561 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants
A Phase 1 study of Opioid Use Disorder, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04448561: Completed Phase 1 study of Opioid Use Disorder, sponsored by Astellas Pharma Global Development.
NCT04448561 is a Phase 1 study of Opioid Use Disorder that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 24 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04448561, a Phase 1 study of Opioid Use Disorder, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this study was to assess the safety and tolerability of multiple doses of ASP8062 or placebo alone and in combination with a single dose of morphine. This study also assessed the potential for pharmacokinetic interaction between ASP8062 and morphine.
Primary Outcome
Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ASP8082
- DRUG morphine
Study Locations (1)
Kansas
- Altasciences Clinical Kansas, Inc. - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2020-09-11 |
| Phase | Phase 1 |
What the finished NCT04448561 record still lists
NCT04448561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04448561 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT04448561 about?
NCT04448561 is a clinical study titled "A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants". The primary purpose of this study was to assess the safety and tolerability of multiple doses of ASP8062 or placebo alone and in combination with a single dose of morphine. This study also assessed the potential for pharmacokinetic interaction between ASP8062 and morphine.
What is the current status of trial NCT04448561?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-06-30. Estimated completion is 2020-09-11.
What conditions does trial NCT04448561 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT04448561?
The interventions under investigation include: Placebo (DRUG), ASP8082 (DRUG), morphine (DRUG).
Who is sponsoring clinical trial NCT04448561?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04448561 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04448561's enrollment target sits among peer trials
24 222nd of 257 higher than 31 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder 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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