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

Not Applicable

Completed

• Conditions: Healthy Adult Male Subjects
• Interventions: Drug: TS-172

• Registration Number: NCT07084961
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-17
• Study First Posted: 2025-07-25
• Study Start: 2025-08-05
• Primary Completion: 2025-09-11
• Study Completion: 2025-09-16
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-01
• Last Update Posted: 2025-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TS-172 20 mg (sequence A)	TS-172	-
TS-172 20 mg (sequence B)	TS-172	-

Primary Outcome Measures

Name	Time	Method
Urinaly excretion of phosphorus	Up to 3 days postdose during each period
Urinaly excretion of sodium	Up to 3 days postdose during each period

Trial Locations

Locations (1)

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