Healthy Male Subjects
Conditions
Brief summary
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
Interventions
DRUGTriazolam and TS-172
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
DRUGTS-172 and itraconazole
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
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Japanese healthy adult males whose age is \>=18 and \<40 years at the time of obtaining informed consent * Subjects whose body mass index is \>=18.5 and \<25.0 at the screening test * Subjects who are judged by a principal investigator or a sub-investigator to be eligible for participation in the study based on the results at the screening test and before administration of the drugs used in the study * Subjects who have been informed of the clinical trial, understand the details of the trial, and give their written consent prior to participation in the trial
Exclusion criteria
* Subjects with medical history ineligible for participation in the study such as of respiratory, cardiovascular, gastrointestinal, hepatic, renal, urologic, endocrine, metabolic, hematologic, immunologic, dermatologic, neurologic, or psychiatric diseases * Subjects with medical history of disease (e.g., stomach or intestinal ulcers) or surgery (e.g., gastrectomy, gastric bandage, gastric bypass) that may affect the absorption of the drugs used in the study * Subjects who have been hospitalized with any treatment or undergone surgery within 12 weeks prior to receiving the drugs used in the study * Subjects with medical history of drug allergies (limited to severe symptoms such as anaphylaxis) or significant allergic predispositions (e.g., asthma that requires treatment) * Subjects who have used medications (including over-the-counter drugs) within 2 weeks prior to receiving the drugs used in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Maximum plasma concentration (Cmax) of unchanged form of triazolam | 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 | 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 | Up to 24 hours postdose |
| Part B: Maximum plasma concentration (Cmax) of unchanged form of TS-172 and its metabolite | 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 | 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 | Up to 48 hours postdose |
Countries
Japan
Outcome results
None listed