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NCT00776516 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers
A Phase 1 study of Pharmacokinetics of YM178, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00776516: Completed Phase 1 study of Pharmacokinetics of YM178, sponsored by Astellas Pharma.
NCT00776516 is a Phase 1 study of Pharmacokinetics of YM178 that has completed, run by Astellas Pharma. 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). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00776516, a Phase 1 study of Pharmacokinetics of YM178, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of the study is to assess the PK, safety and tolerability of a single dose of mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.
Conditions Studied
Interventions
- DRUG mirabegron
- DRUG rifampin
Study Locations (1)
Florida
- - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
What the finished NCT00776516 record still lists
NCT00776516 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 1 condition, with Pharmacokinetics of YM178 appearing as the primary indexed condition, and to 2 interventions - of which mirabegron is the first listed.
NCT00776516 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00776516 about?
NCT00776516 is a clinical study titled "Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers". The objective of the study is to assess the PK, safety and tolerability of a single dose of mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.
What is the current status of trial NCT00776516?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-10. Estimated completion is 2008-12.
What conditions does trial NCT00776516 study?
This clinical trial studies the following conditions: Pharmacokinetics of YM178.
What interventions are being tested in trial NCT00776516?
The interventions under investigation include: mirabegron (DRUG), rifampin (DRUG).
Who is sponsoring clinical trial NCT00776516?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00776516 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00776516'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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