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NCT04003402 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects
A Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04003402: Completed Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
NCT04003402 is a Phase 1 study of Healthy Volunteers that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 20 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04003402, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the potential for pharmacokinetic (PK) and pharmacodynamics (PD) interactions between ASP8062 and alcohol. This study will also assess safety and tolerability of a single dose of ASP8062 with or without alcohol.
Primary Outcome
AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.
Conditions Studied
Interventions
- DRUG Alcohol
- DRUG ASP8062
- DRUG ASP8062 Placebo
- DRUG Alcohol Placebo
Study Locations (1)
Maryland
- Parexel International - EPCU Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-07-16 |
| Est. Completion | 2019-10-16 |
| Phase | Phase 1 |
What the finished NCT04003402 record still lists
NCT04003402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions - of which Alcohol is the first listed.
NCT04003402 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04003402 about?
NCT04003402 is a clinical study titled "A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects". The purpose of this study is to assess the potential for pharmacokinetic (PK) and pharmacodynamics (PD) interactions between ASP8062 and alcohol. This study will also assess safety and tolerability of a single dose of ASP8062 with or without alcohol.
What is the current status of trial NCT04003402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-07-16. Estimated completion is 2019-10-16.
What conditions does trial NCT04003402 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04003402?
The interventions under investigation include: Alcohol (DRUG), ASP8062 (DRUG), ASP8062 Placebo (DRUG), Alcohol Placebo (DRUG).
Who is sponsoring clinical trial NCT04003402?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04003402 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04003402's enrollment target sits among peer trials
20 222nd of 283 higher than 59 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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