A Drug-drug Interaction Study With TS-172 in Healthy Adult Male Subjects

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Drug: Triazolam and TS-172; Drug: TS-172 and itraconazole

• Registration Number: NCT06837142
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-16
• Study First Posted: 2025-02-20
• Study Start: 2025-03-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triazolam and TS-172 (part A)	Triazolam and TS-172	-
TS-172 and itraconazole (part B)	TS-172 and itraconazole	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan