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

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

Official Title
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An Open-label Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment

Conditions
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Patients With Mild or Moderate Hepatic Impairment

Intervention / Treatment
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* Drug: TS-142 5 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild hepatic impairment<br>Patients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142 | Drug: TS-142 5 mg<br>* Single-dose of 5 mg of TS-142<br>|
| Experimental: Moderate hepatic impairment<br>Patients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142 | Drug: TS-142 5 mg<br>* Single-dose of 5 mg of TS-142<br>|
| Experimental: Normal hepatic function<br>Subjects with normal hepatic function will receive a single-dose of 5 mg of TS-142 | Drug: TS-142 5 mg<br>* Single-dose of 5 mg of TS-142<br>|

What is the study measuring?
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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 |