A Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TS-172.
- Who it may be relevant to
- Registry conditions: Patients With Mild or Moderate Hepatic Impairment. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment
Overview
An open-label study to evaluate the effect of TS-172 administration on pharmacokinetics in patients with hepatic impairment
Interventions
- Drug TS-172
Single oral administration of TS-172 20mg
Primary outcome measures
- Plasma concentrations of unchanged form and metabolites [Time frame: Up to 48 hours after dosing]
Eligibility criteria
<Inclusion criteria for patients with hepatic impairment>
- Japanese male and female patients whose age is >=18 and <=75 years at the time of obtaining informed consent
- Patients with chronic hepatic impairment
- Patients who were classified by the principal investigator or sub-investigator as Class A (mild) or Class B (moderate) by Child-Pugh classification at the screening test Other protocol defined inclusion criteria could apply.
<Inclusion criteria for subjects with normal hepatic function>
- Japanese male and female patients whose age is >=18 and <=75 years at the time of obtaining informed consent
- Subjects whose body mass index is >=18.5 and <35.0 at the screening test Other protocol defined inclusion criteria could apply.
<Exclusion criteria for patients with hepatic impairment>
- Patients with medical history of liver resection or liver transplantation
- Patients with grade II or higher hepatic encephalopathy
- Patients whose eGFR is <45 mL/min/1.73 m2 at screening test Other protocol defined exclusion criteria could apply.
<Exclusion criteria for subjects with normal hepatic function>
- Subjects with current condition or medical history of diseases that are ineligible for participation in the study
- Subjects whose eGFR is <60 mL/min/1.73 m2 at screening test Other protocol defined exclusion criteria could apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Taisho Pharmaceutical Co., Ltd selected site — Tokyo
Identifiers
NCT: NCT07231029 · TS172-03-10