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

Taisho Pharmaceutical

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy Adult Male Subjects

Treatments: Drug: TS-172

Study type: Interventional

Funder types: Industry

Identifiers

NCT07084961

TS172-03-09

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: Male

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

TS-172 20 mg (sequence A)

Experimental group

Treatment:

Drug: TS-172

Drug: TS-172

TS-172 20 mg (sequence B)

Experimental group

Treatment:

Drug: TS-172

Drug: TS-172