The study aims to evaluate if blood levels of desipramine change whilst being dosed at the same time with daily mirabegron.
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.
Study Type
INTERVENTIONAL
Masking
NONE
Enrollment
28
oral
oral
SGS Aster
Paris, France
Pharmacokinetics of desipramine assessed by plasma concentration while at steady state levels of mirabegron
Time frame: Pre-dose until 72 hours after dosing
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)
Pharmacokinetics of desipramine assessed by plasma concentration after wash-out of mirabegron
Time frame: Pre-dose until 72 hours after wash-out
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.