An open-label, single-center, single-sequence study to evaluate the drug-drud interaction between the CYP3A substrate triazolam and TS-172 (part A) and the potent CYP3A inhibitor itraconazole and TS-172 (part B) in healthy male subjects on their pharmacokinetics, safety and tolerability
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral single administration of triazolam 0.25 mg at single administration phase, followed by a oral single administration of triazolam 0.25 mg and TS-172 20 mg at concomitant administration phase
Oral single administrtation of TS-172 20 mg at single administration phase, followed by a oral single administration of TS-172 and itoraconazole 200 mg at concomitant administration phase
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan
Part A: Maximum plasma concentration (Cmax) of unchanged form of triazolam
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after dosing
Part A: Area under the concentration-time curve (AUC) from time zero to time of the last quantifiable concentration of unchanged form of triazolam in plasma
Time frame: Up to 24 hours postdose
Part A: Area under the concentration-time curve (AUC) from time zero extrapolated to infinite time of unchanged form of triazolam in plasma
Time frame: Up to 24 hours postdose
Part B: Maximum plasma concentration (Cmax) of unchanged form of TS-172 and its metabolite
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours after dosing
Part B: Area under the concentration-time curve (AUC) from time zero to time of the last quantifiable concentration of unchanged form of TS-172 and its metabolite in plasma
Time frame: Up to 48 hours postdose
Part B: Area under the concentration-time curve (AUC) from time zero extrapolated to infinite time of unchanged form of TS-172 and its metabolite in plasma
Time frame: Up to 48 hours postdose
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