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

An Open-label 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

Study Overview

• Status: Completed
• Conditions: Patients With Mild or Moderate Hepatic Impairment
• Intervention / Treatment: Drug: TS-142 5 mg

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Taisho Pharmaceutical Co., Ltd.; Phone Number: 81-3-3985-1118; Email: clinical-trials_CTG@taisho.co.jp

Study Locations

• Japan
  • Tokyo, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

<Inclusion criteria for patients with hepatic impairment>

1. Japanese male and female who are aged 18 to 75 years at the time of informed consent
2. Patients with cirrhosis or chronic hepatic impairment
3. 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>

1. Japanese male and female who are aged 18 to 75 years at the time of informed consent
2. 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>

1. Patients who have a history of liver resection or liver transplant
2. Patients with hepatic encephalopathy of grade II or higher
3. 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>

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Single-dose of 5 mg of TS-142
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; Single-dose of 5 mg of TS-142
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; Single-dose of 5 mg of TS-142

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From administration of investigational product through 10 days after administration of investigational product

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2022
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: TS142-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No