Clinical trial NCT06837142: A Drug-drug Interaction Study With TS-172 in Healthy Adult Male Subjects
Official title: A Drug-drug Interaction Study With TS-172 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Part A: Maximum plasma concentration (Cmax) of unchanged form of triazolam
timeFrame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after dosing
measure: 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
timeFrame: Up to 24 hours postdose
measure: Part A: Area under the concentration-time curve (AUC) from time zero extrapolated to infinite time of unchanged form of triazolam in plasma
timeFrame: Up to 24 hours postdose
measure: Part B: Maximum plasma concentration (Cmax) of unchanged form of TS-172 and its metabolite
timeFrame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours after dosing
measure: 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
timeFrame: Up to 48 hours postdose
measure: 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
timeFrame: Up to 48 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
References: