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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-22

Study Completion Date

2025-04-24

Brief Summary

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

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Detailed Description

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Conditions

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Patients on Hemodialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TS-172

Group Type EXPERIMENTAL

TS-172

Intervention Type DRUG

oral administration of TS-172 20 mg

Interventions

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TS-172

oral administration of TS-172 20 mg

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No