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NCT02571816 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02571816: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT02571816 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02571816, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function. This study will also assess the safety and tolerability of single-dose ASP2215 in subjects with mild and moderate hepatic impairment and matched control subjects.
Primary Outcome
Area under the curve from time zero to infinity (AUCinf)
Interventions
- DRUG ASP2215
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-10-23 |
| Est. Completion | 2016-03-05 |
| Phase | Phase 1 |
What the finished NCT02571816 record still lists
NCT02571816 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which ASP2215 is the first listed.
NCT02571816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02571816 about?
NCT02571816 is a clinical study titled "A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215". The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function. This study will also assess the safety and tolerability of single-dose ASP2215 in subjects with mild an...
What is the current status of trial NCT02571816?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-10-23. Estimated completion is 2016-03-05.
What interventions are being tested in trial NCT02571816?
The interventions under investigation include: ASP2215 (DRUG).
Who is sponsoring clinical trial NCT02571816?
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 NCT02571816's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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