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OpenTrials
Completed

NCT Number: NCT06849778

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

Completed

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Key information

Age range

18 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

TS-172

Drug

oral administration of TS-172 20 mg

Primary outcomes

  1. Concentration of unchanged form in plasma

    Time frame: Day 1, 2, 8 and 9

  2. Concentration of major metabolites in plasma

    Time frame: Day 1, 2, 8 and 9

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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