NCT07084961

CompletedPhase 1

A Pharmacodynamic Study of TS-172 in Healthy Adult Male Subj...

Taisho Pharmaceutical Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

TS172-03-09

Study Type

interventional

Actual enrollment (reported)

16

Locations

1 country

Sites

1

Timeline

Study Start

August 5, 2025

Actual (reported)

Primary Completion

September 11, 2025

Actual (reported)

Study Completion

September 16, 2025

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 16 participants
Study completion date: September 16, 2025
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 17, 2025
Actual (reported)
First Posted
July 25, 2025
Actual (reported)
Study Start
August 5, 2025
Actual (reported)
Primary Completion
September 11, 2025
Actual (reported)
Study Completion
September 16, 2025
Actual (reported)

Last Updated: October 3, 2025
Status Verified: October 2025
Last Update Submitted: October 1, 2025

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-172Drug

Oral administration of TS-172 20 mg immediately before meal

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

TS-172Drug

Oral administration of TS-172 20 mg immediately after meal

TS-172 20 mg (sequence A)

Eligibility Criteria

Age18 Years - 39 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

Taisho Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Study Officials

Taisho Director Taisho Director
Taisho Pharmaceutical Co., Ltd.
STUDY DIRECTOR

Enrollment

16 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

NCT06745518

A Phase 2 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders

Phase 2Completed

NCT01909986

A Human Mass Balance Study to Determine the Total Recovery of Radioactivity in Urine and Faeces Following a Single Oral Dose of 14C Radiolabelled ONO-4053

Phase 1Completed

TS-172 20 mg (sequence B)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Contact the study team to confirm eligibility.

September 11, 2025

Actual (reported)

Study Completion

September 16, 2025

Actual (reported)

Last Updated

October 3, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07084961
Data provider: ClinicalTrials.gov
Source updated: 2025-10-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:21 UTC

Locations

JP(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

TS-172 20 mg (sequence A)

TS-172 20 mg (sequence B)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations