Clinical trial NCT05624944: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Patients with Mild or Moderate Hepatic Impairment
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma concentration
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
measure: Pharmacokinetic parameters
timeFrame: Predose and up to 48 hours postdose
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: From administration of investigational product through 10 days after administration of investigational product
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References: