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

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: Triazolam and TS-172; Drug: TS-172 and itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06837142

TS172-03-05

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Triazolam and TS-172 (part A)

Experimental group

Treatment:

Drug: Triazolam and TS-172

TS-172 and itraconazole (part B)

Experimental group

Treatment:

Drug: TS-172 and itraconazole