NCT06849778

CompletedPhase 1

An Open-label Pharmacokinetic Study of TS-172 in Patients on...

Taisho Pharmaceutical Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

TS172-03-04

Study Type

interventional

Actual enrollment (reported)

7

Locations

1 country

Sites

1

Timeline

Study Start

March 22, 2025

Actual (reported)

Primary Completion

April 24, 2025

Actual (reported)

Study Completion

April 24, 2025

Actual (reported)

Brief Summary

A phase 1, open-label, pharmacokinetic study of TS-172 in patients on hemodialysis

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): 7 participants
Study completion date: April 24, 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
February 16, 2025
Actual (reported)
First Posted
February 27, 2025
Actual (reported)
Study Start
March 22, 2025
Actual (reported)
Primary Completion
April 24, 2025
Actual (reported)
Study Completion
April 24, 2025
Actual (reported)

Last Updated: May 15, 2025
Status Verified: May 2025
Last Update Submitted: May 13, 2025

Conditions

Patients on Hemodialysis

Outcome Measures

Primary Outcomes (2)

Concentration of unchanged form in plasma
Day 1, 2, 8 and 9
Concentration of major metabolites in plasma
Day 1, 2, 8 and 9

Study Arms (1)

TS-172

EXPERIMENTAL

Drug: TS-172

Interventions

TS-172Drug

oral administration of TS-172 20 mg

TS-172

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

Eligibility Criteria

Age18 Years - 74 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Japanese male patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to the screening test
Patients aged \>= 18 and \< 75 years at the time of obtaining informed consent

Sponsors & Collaborators

Taisho Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Study Officials

Taisho Director
Taisho Pharmaceutical Co., Ltd.
STUDY DIRECTOR

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 16, 2025

First Posted

February 27, 2025

Study Start

March 22, 2025

Actual (reported)

NCT06745518

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

Phase 2Completed

NCT07506980

Nurse Led Intervention on Self Care Adherence and Quality of Life

Not ApplicableRecruiting

You may not qualify if:

Patients with gastric or intestinal ulceration or a history of them within the past year prior to the date of initiation of treatment, or patients with inflammatory bowel disease or irritable bowel syndrome, or a history of these within the past 5 years prior to the date of initiation of treatment
Patients scheduled for renal transplantation, home hemodialysis or change of dialysis facility (transfer or temporary dialysis at other hospital) during the study period
Patients who frequently experience diarrhea (defined as Bristol Stool Scale score of 6 or higher)

Contact the study team to confirm eligibility.

Primary Completion

April 24, 2025

Actual (reported)

Study Completion

April 24, 2025

Actual (reported)

Last Updated

May 15, 2025

Record last verified: 2025-05

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: NCT06849778
Data provider: ClinicalTrials.gov
Source updated: 2025-05-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:30 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 (1)

TS-172

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