NCT00776516

Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers

A Phase 1, Open-Label, Drug Interaction Study to Evaluate the Effect of Repeat Doses of Rifampin on the Single-Dose Pharmacokinetics of Mirabegron (YM178)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

A single group of patients will receive both mirabegron alone and in combination with rifampin

Conditions

• Pharmacokinetics of YM178

Interventions

Type	Name	Description
DRUG	mirabegron	oral
DRUG	rifampin	oral

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-10-21
• Last updated: 2013-07-03

Locations

1 site across 1 country: United States