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

Primary Purpose

Patients With Mild or Moderate Hepatic Impairment

Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
TS-142 5 mg
Sponsored by
Taisho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Mild or Moderate Hepatic Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Taisho Pharmaceutical Co., Ltd selected siteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mild hepatic impairment

Moderate hepatic impairment

Normal hepatic function

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 11, 2022
Last Updated
July 20, 2023
Sponsor
Taisho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05624944
Brief Title
A Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment
Official Title
An Open-label Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taisho Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Mild or Moderate Hepatic Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mild hepatic impairment
Arm Type
Experimental
Arm Description
Patients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142
Arm Title
Moderate hepatic impairment
Arm Type
Experimental
Arm Description
Patients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142
Arm Title
Normal hepatic function
Arm Type
Experimental
Arm Description
Subjects with normal hepatic function will receive a single-dose of 5 mg of TS-142
Intervention Type
Drug
Intervention Name(s)
TS-142 5 mg
Intervention Description
Single-dose of 5 mg of TS-142
Primary Outcome Measure Information:
Title
Plasma concentration
Description
Plasma concentration of unchanged form and its metabolite
Time Frame
Predose and up to 48 hours postdose
Title
Pharmacokinetic parameters
Description
Maximum plasma concentration of unchanged form and its metabolite (Cmax)
Time Frame
Predose and up to 48 hours postdose
Title
Pharmacokinetic parameters
Description
Time to maximum plasma concentration of unchanged form and its metabolite (tmax)
Time Frame
Predose and up to 48 hours postdose
Title
Pharmacokinetic parameters
Description
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
Title
Pharmacokinetic parameters
Description
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
Title
Pharmacokinetic parameters
Description
Terminal elimination rate constant of unchanged form and its metabolite (λz)
Time Frame
Predose and up to 48 hours postdose
Title
Pharmacokinetic parameters
Description
Elimination half-life of unchanged form and its metabolite (t1/2)
Time Frame
Predose and up to 48 hours postdose
Title
Pharmacokinetic parameters
Description
Apparent volume of distribution based on the terminal phase of unchanged form (Vz/F)
Time Frame
Predose and up to 48 hours postdose
Title
Pharmacokinetic parameters
Description
Apparent total body clearance of unchanged form (CL/F)
Time Frame
Predose and up to 48 hours postdose
Title
Pharmacokinetic parameters
Description
Plasma unbound fraction of unchanged form and its metabolite (fu)
Time Frame
Predose and up to 48 hours postdose
Title
Pharmacokinetic parameters
Description
Maximum plasma concentration adjusted by unbound fraction of unchanged form (Cmax(unbound))
Time Frame
Predose and up to 48 hours postdose
Title
Pharmacokinetic parameters
Description
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
Title
Pharmacokinetic parameters
Description
Apparent total body clearance adjusted by unbound fraction of unchanged form (CL(unbound)/F)
Time Frame
Predose and up to 48 hours postdose
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
"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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taisho Pharmaceutical Co., Ltd.
Phone
81-3-3985-1118
Email
clinical-trials_CTG@taisho.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taisho Director
Organizational Affiliation
Taisho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Taisho Pharmaceutical Co., Ltd selected site
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taisho Director

12. IPD Sharing Statement

Plan to Share IPD
No

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

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