The study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy poor or extensive metabolizers for CYP2D6 and to evaluate if blood levels of metoprolol change whilst being dosed at the same time with daily miragebron.
The study is an open label, single center study. All subjects are genotyped for CYP2D6 before the study. Genotype expression is confirmed by dextromethorphan phenotyping. Part I: The pharmacokinetic profile of a single dose of YM178 is compared in 8 healthy male subjects genotyped and phenotyped as poor metaboliser (PM) for CYP2D6 and in 8 healthy male subjects genotyped and phenotyped as extensive metaboliser (EM) for CYP2D6. Part II: The effect of YM178 on the model substrate of CYP2D6 metoprolol is evaluated, using a cross-over design, in 12 healthy male subjects genotyped and phenotyped as EM for CYP2D6.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
28
oral
oral
PRA International (former Pharma Bio-Research)
Zuidlaren, Netherlands
Pharmacokinetics of mirabegron assessed by plasma concentration
Primary outcome measure for Part 1
Time frame: Pre-dose until 72 hours after dosing
Pharmacokinetics of metoprolol assessed by plasma concentration
Primary outcome measure for Part 2
Time frame: Pre-dose until 48 hours after dosing
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