Trials Sponsors Conditions Drugs Pricing

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

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

Interventions

TS-142 5 mgDrug

Single-dose of 5 mg of TS-142

Mild hepatic impairmentModerate hepatic impairmentNormal hepatic function

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Taisho Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

MeSH Terms

Interventions

TS-142

Study Officials

Taisho Director
Taisho Pharmaceutical Co., Ltd.
STUDY DIRECTOR

Enrollment

84 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (13)

Secondary Outcomes (1)

Study Arms (3)

Mild hepatic impairment

Moderate hepatic impairment

Normal hepatic function

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (13)

Secondary Outcomes (1)

Study Arms (3)

Mild hepatic impairment

Moderate hepatic impairment

Normal hepatic function

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations