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

NCT ID: NCT06837142

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2025-04-30

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

Conditions

Healthy Male Subjects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triazolam and TS-172 (part A)

Group Type: EXPERIMENTAL

Triazolam and TS-172

Intervention Type: DRUG

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

TS-172 and itraconazole (part B)

Group Type: EXPERIMENTAL

TS-172 and itraconazole

Intervention Type: DRUG

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

Interventions

Triazolam 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

Intervention Type: DRUG

TS-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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, , Japan

Countries

Japan

Other Identifiers

TS172-03-05

Identifier Type: -

Identifier Source: org_study_id