NCT05624944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 26, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
Last Updated

February 28, 2025

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

November 11, 2022

Last Update Submit

February 26, 2025

Conditions

Patients with Mild or Moderate Hepatic Impairment

Outcome Measures

Primary Outcomes (13)

  • Plasma concentration

    Plasma concentration of unchanged form and its metabolite

    Predose and up to 48 hours postdose

  • Pharmacokinetic parameters

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

    Predose and up to 48 hours postdose

  • Pharmacokinetic parameters

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

    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)

    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)

    Predose and up to 48 hours postdose

  • Pharmacokinetic parameters

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

    Predose and up to 48 hours postdose

  • Pharmacokinetic parameters

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

    Predose and up to 48 hours postdose

  • Pharmacokinetic parameters

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

    Predose and up to 48 hours postdose

  • Pharmacokinetic parameters

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

    Predose and up to 48 hours postdose

  • Pharmacokinetic parameters

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

    Predose and up to 48 hours postdose

  • Pharmacokinetic parameters

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

    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))

    Predose and up to 48 hours postdose

  • Pharmacokinetic parameters

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

    Predose and up to 48 hours postdose

Secondary Outcomes (1)

  • Incidence of adverse events

    From administration of investigational product through 10 days after administration of investigational product

Study Arms (3)

Mild hepatic impairment

EXPERIMENTAL

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

Drug: TS-142 5 mg

Moderate hepatic impairment

EXPERIMENTAL

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

Drug: TS-142 5 mg

Normal hepatic function

EXPERIMENTAL

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

Drug: TS-142 5 mg

Interventions

TS-142 5 mgDRUG

Single-dose of 5 mg of TS-142

Mild hepatic impairmentModerate hepatic impairmentNormal hepatic function

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who have a history of liver resection or liver transplant
  • Patients with hepatic encephalopathy of grade II or higher
  • Subjects who are judged to have any disease by the principal investigator or sub-investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

TS-142

Study Officials

  • Taisho Director

    Taisho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2022

First Posted

November 22, 2022

Study Start

December 26, 2022

Primary Completion

December 5, 2023

Study Completion

December 5, 2023

Last Updated

February 28, 2025

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)