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

NCT06849778 | Completed Phase 1

• 1 other identifier: TS172-03-04
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

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-172 DRUG

oral administration of TS-172 20 mg

TS-172

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (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

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)

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

Study Officials

• Taisho Director

  Taisho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

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
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)