CompletedNCT05624944Updated Feb 28, 2025

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

A Phase 1 interventional study of TS-142 5 mg in Patients with Mild or Moderate Hepatic Impairment, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Taisho Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 84
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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

Conditions studied

Patients with Mild or Moderate Hepatic Impairment

Browse trials for

Liver Diseases 2,081

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 84 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 41 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

\<Inclusion criteria for patients with hepatic impairment>

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

Japanese male and female who are aged 18 to 75 years at the time of informed consent
Body Mass Index (BMI) between 18.5 and 35.0 at the screening test Other protocol defined inclusion criteria could apply.

Exclusion criteria

Exclusion Criteria:

\<Exclusion criteria for patients with hepatic impairment>

Patients who have a history of liver resection or liver transplant
Patients with hepatic encephalopathy of grade II or higher
Patients with epidermal growth factor receptor (eGFR) less than 45 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.

\<Exclusion criteria for subjects with normal hepatic function>

Subjects who are judged to have any disease by the principal investigator or sub-investigator
Subjects with eGFR less than 60 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 84 participants (actual)

Study arms

Experimental
Mild hepatic impairment
Patients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142
Drug: TS-142 5 mg
Experimental
Moderate hepatic impairment
Patients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142
Drug: TS-142 5 mg
Experimental
Normal hepatic function
Subjects with normal hepatic function will receive a single-dose of 5 mg of TS-142
Drug: TS-142 5 mg

Interventions

DrugTS-142 5 mg
Single-dose of 5 mg of TS-142

What researchers measure

Primary outcomes

Plasma concentration
Plasma concentration of unchanged form and its metabolite
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Maximum plasma concentration of unchanged form and its metabolite (Cmax)
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Time to maximum plasma concentration of unchanged form and its metabolite (tmax)
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf)
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of unchanged form and its metabolite (AUC0-last)
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Terminal elimination rate constant of unchanged form and its metabolite (λz)
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Elimination half-life of unchanged form and its metabolite (t1/2)
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Apparent total body clearance of unchanged form (CL/F)
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Plasma unbound fraction of unchanged form and its metabolite (fu)
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Maximum plasma concentration adjusted by unbound fraction of unchanged form (Cmax(unbound))
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Area under the plasma concentration-time curve extrapolated to infinity adjusted by unbound fraction of unchanged form (AUC(unbound))
Time frame: Predose and up to 48 hours postdose
Pharmacokinetic parameters
Apparent total body clearance adjusted by unbound fraction of unchanged form (CL(unbound)/F)
Time frame: Predose and up to 48 hours postdose

Secondary outcomes

Incidence of adverse events
"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.
Time frame: From administration of investigational product through 10 days after administration of investigational product

Study locations

1 site

Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05624944
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Nov 22, 2022
Start date: Dec 26, 2022
Primary completion: Dec 5, 2023
Completion: Dec 5, 2023
Last update: Feb 28, 2025

Study contacts

Taisho Director

study director · Taisho Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Liver Diseases→

Other studies from this sponsor

Taisho Pharmaceutical Co., Ltd.

Start the discussion