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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 is a Phase 1 study of Pharmacokinetics of YM178 that has completed, run by Astellas Pharma. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00776516
The ClinicalTrials.gov registry entry for NCT00776516 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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