The purpose of this study is to assess in healthy adult male participants the effects of itraconazole on the pharmacokinetics of venglustat and to assess the safety and tolerability of venglustat with and without coadministration of itraconazole. The maximum duration for participants from screening is between 32 to 62 days.
Total study duration for participants is up to 62 days including screening up to 28 days, 1 day of treatment in period 1, washout of 7 days, 13 days of treatment in period 2, and follow up period 10-14 days after last dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Pharmaceutical form:Capsule-Route of administration:Oral
Pharmaceutical form:Capsule-Route of administration:Oral
PPD
Austin, Texas, United States
Area under the plasma concentration versus time curve (AUC) of venglustat
Time frame: Multiple time points up to 21 days
Area under the plasma concentration versus time curve calculated from time zero to the real time (tlast) (AUClast) of venglustat
Time frame: Multiple time points up to 21 days
Maximum plasma concentration observed (Cmax) of venglustat
Time frame: Multiple time points up to 21 days
Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of venglustat
Time frame: Multiple time points up to 21 days
Time to reach Cmax (tmax) of venglustat
Time frame: Multiple time points up to 21 days
Terminal half-life (t1/2) of venglustat
Time frame: Multiple time points up to 21 days
Maximum plasma concentration observed (Cmax) of itraconazole
Time frame: Multiple time points up to 21 days
Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of itraconazole
Time frame: Multiple time points up to 21 days
Time to reach Cmax (tmax) of itraconazole
Time frame: Multiple time points up to 21 days
Area under the plasma concentration versus time curve calculated over the dosing interval (12 h) (AUC0-12) of itraconazole
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Time frame: Multiple time points up to 21 days
Maximum plasma concentration observed (Cmax) of hydroxyitraconazole
Time frame: Multiple time points up to 21 days
Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of hydroxyitraconazole
Time frame: Multiple time points up to 21 days
Time to reach Cmax (tmax) of hydroxyitraconazole
Time frame: Multiple time points up to 21 days
Area under the plasma concentration versus time curve over the dosing interval (12 h) (AUC0-12) of hydroxyitraconazole
Time frame: Multiple time points up to 21 days