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

NCT07084961 | Completed Phase 1

• 1 other identifier: TS172-03-09
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Male Subjects

Outcome Measures

Primary Outcomes (2)

• Urinaly excretion of phosphorus

  Up to 3 days postdose during each period

• Urinaly excretion of sodium

  Up to 3 days postdose during each period

Study Arms (2)

TS-172 20 mg (sequence A)

EXPERIMENTAL

Drug: TS-172

TS-172 20 mg (sequence B)

EXPERIMENTAL

Drug: TS-172

Interventions

TS-172 DRUG

Oral administration of TS-172 20 mg immediately before meal

TS-172 20 mg (sequence A); TS-172 20 mg (sequence B)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

Study Officials

• Taisho Director Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: August 5, 2025
• Primary Completion: September 11, 2025
• Study Completion: September 16, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)