To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together
The study aims to evaluate if blood levels of desipramine change whilst being dosed at the same time with daily mirabegron.
Pharmacokinetics of Mirabegron
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of the CYP2D6 Substrate Desipramine in Healthy Subjects|
- Pharmacokinetics of desipramine assessed by plasma concentration while at steady state levels of mirabegron [ Time Frame: Pre-dose until 72 hours after dosing ] [ Designated as safety issue: No ]
- Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events [ Time Frame: Baseline until End of Study Visit (7 to 14 days after last dose) ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of desipramine assessed by plasma concentration after wash-out of mirabegron [ Time Frame: Pre-dose until 72 hours after wash-out ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|Experimental: mirabegron / desipramine||
Other Name: YM178Drug: desipramine
This is an open-label, one-sequence crossover design study to evaluate the drug-drug interaction between mirabegron and desipramine. The effect of mirabegron on the plasma concentration of desipramine will be evaluated after 13 day repeated administration. The recovery of CYP2D6 activity is also being explored by comparing the pharmacokinetic profiles of desipramine after a 2 week wash-out period.