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

A Phase 1, Open-label, Pharmacokinetic Study of TS-172 in Patients on Hemodialysis

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

Study Overview

• Status: Completed
• Conditions: Patients on Hemodialysis
• Intervention / Treatment: Drug: TS-172

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Patients aged >= 18 and < 75 years at the time of obtaining informed consent

Exclusion Criteria:

1. 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
2. Patients scheduled for renal transplantation, home hemodialysis or change of dialysis facility (transfer or temporary dialysis at other hospital) during the study period
3. Patients who frequently experience diarrhea (defined as Bristol Stool Scale score of 6 or higher)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TS-172	Drug: TS-172; oral administration of TS-172 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of unchanged form in plasma	Day 1, 2, 8 and 9
Concentration of major metabolites in plasma	Day 1, 2, 8 and 9

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2025
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): April 24, 2025

Study Registration Dates

• First Submitted: February 16, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: TS172-03-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No