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

Phase 1

Completed

• Conditions: Patients on Hemodialysis
• Interventions: Drug: TS-172

• Registration Number: NCT06849778
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-27
• Study Start: 2025-03-22
• Primary Completion: 2025-04-24
• Study Completion: 2025-04-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TS-172	TS-172	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

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