A Pharmacodynamic Study of TS-172 in Healthy Adult Male Subjects

NCT07084961•Taisho Pharmaceutical Co., Ltd.

Summary

An open-label, single-center, crossover study to evaluate the impact of administration timing of TS-172 on the pharmacodynamics in healthy adult male subjects.

Eligibility

Age

18 - 39 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Japanese healthy adult males whose age is \>=18 and \<40 years at the time of obtaining informed consent
•2. Subjects whose body mass index is \>=18.5 and \<25.0 at the screening test
•3. 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
•4. 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

•1. 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
•2. 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
•3. Subjects who have been hospitalized with any treatment or undergone surgery within 12 weeks prior to receiving the drugs used in the study
•4. Subjects with medical history of drug allergies (limited to severe symptoms such as anaphylaxis) or significant allergic predispositions (e.g., asthma that requires treatment)
•5. Subjects who have used medications (including over-the-counter drugs) within 2 weeks prior to receiving the drugs used in the study

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Key Dates

Start Date

August 5, 2025

Primary Completion Date

September 11, 2025

Completion Date

September 16, 2025

Last Updated

October 3, 2025

Enrollment

ACTUAL participants

Conditions

Healthy Adult Male Subjects

Interventions

TS-172

DRUG

TS-172

DRUG