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

An Open-label Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05624944

Enrollment

Registered

2022-11-22

Start date

2022-12-26

Completion date

2023-12-05

Last updated

2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Mild or Moderate Hepatic Impairment

Brief summary

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

Interventions

DRUGTS-142 5 mg

Single-dose of 5 mg of TS-142

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

\<Inclusion criteria for patients with hepatic impairment\> 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 3. Patients classified as Child-Pugh classification A (mild) or B (moderate) by the principal investigator or sub-investigator at the screening test Other protocol defined inclusion criteria could apply. \<Inclusion criteria for subject with normal hepatic function\> 1. Japanese male and female who are aged 18 to 75 years at the time of informed consent 2. Body Mass Index (BMI) between 18.5 and 35.0 at the screening test Other protocol defined inclusion criteria could apply.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Plasma concentration	Predose and up to 48 hours postdose	Plasma concentration of unchanged form and its metabolite
Pharmacokinetic parameters	Predose and up to 48 hours postdose	Maximum plasma concentration of unchanged form and its metabolite (Cmax)

Secondary

Measure	Time frame	Description
Incidence of adverse events	From administration of investigational product through 10 days after administration of investigational product	Adverse event refers to any unfavorable or unintended disease or symptom thereof (including abnormal laboratory tests values) occurring in a subject who has been administered an investigational product, whether or not there is a causal relationship with the investigational product.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026