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Completed

NCT Number: NCT05624944

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

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

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Key information

Conditions

Patients With Mild or Moderate Hepatic Impairment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

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 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.

Treatment and study plan

TS-142 5 mg

Drug

Single-dose of 5 mg of TS-142

Primary outcomes

  1. Plasma concentration

    Time frame: Predose and up to 48 hours postdose

    Plasma concentration of unchanged form and its metabolite

  2. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Maximum plasma concentration of unchanged form and its metabolite (Cmax)

  3. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Time to maximum plasma concentration of unchanged form and its metabolite (tmax)

  4. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Area under the plasma concentration-time curve extrapolated to infinity of unchanged form and its metabolite (AUCinf)

  5. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    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)

  6. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Terminal elimination rate constant of unchanged form and its metabolite (λz)

  7. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Elimination half-life of unchanged form and its metabolite (t1/2)

  8. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)

  9. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Apparent total body clearance of unchanged form (CL/F)

  10. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Plasma unbound fraction of unchanged form and its metabolite (fu)

  11. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Maximum plasma concentration adjusted by unbound fraction of unchanged form (Cmax(unbound))

  12. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Area under the plasma concentration-time curve extrapolated to infinity adjusted by unbound fraction of unchanged form (AUC(unbound))

  13. Pharmacokinetic parameters

    Time frame: Predose and up to 48 hours postdose

    Apparent total body clearance adjusted by unbound fraction of unchanged form (CL(unbound)/F)

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2022
Registry last updated
Feb 28, 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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