A Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-26

Study Completion Date

2023-12-05

Brief Summary

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This is an open-label pharmacokinetic study of TS-142 in patients with hepatic impairment

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Detailed Description

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Conditions

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Patients with Mild or Moderate Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild hepatic impairment

Patients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142

Group Type EXPERIMENTAL

TS-142 5 mg

Intervention Type DRUG

Single-dose of 5 mg of TS-142

Moderate hepatic impairment

Patients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142

Group Type EXPERIMENTAL

TS-142 5 mg

Intervention Type DRUG

Single-dose of 5 mg of TS-142

Normal hepatic function

Subjects with normal hepatic function will receive a single-dose of 5 mg of TS-142

Group Type EXPERIMENTAL

TS-142 5 mg

Intervention Type DRUG

Single-dose of 5 mg of TS-142

Interventions

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TS-142 5 mg

Single-dose of 5 mg of TS-142

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Japanese male and female who are aged 18 to 75 years at the time of informed consent
2. Patients with cirrhosis or chronic hepatic impairment

1. Japanese male and female who are aged 18 to 75 years at the time of informed consent

Exclusion Criteria

1. Patients who have a history of liver resection or liver transplant
2. Patients with hepatic encephalopathy of grade II or higher

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes