Patients With Mild or Moderate Hepatic Impairment
Conditions
Brief summary
An open-label study to evaluate the effect of TS-172 administration on pharmacokinetics in patients with hepatic impairment
Interventions
DRUGTS-172
Single oral administration of TS-172 20mg
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\<Inclusion criteria for patients with hepatic impairment\> 1. Japanese male and female patients whose age is \>=18 and \<=75 years at the time of obtaining informed consent 2. Patients with chronic hepatic impairment 3. 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\> 1. Japanese male and female patients whose age is \>=18 and \<=75 years at the time of obtaining informed consent 2. 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\> 1. Patients with medical history of liver resection or liver transplantation 2. Patients with grade II or higher hepatic encephalopathy 3. Patients whose eGFR is \<45 mL/min/1.73 m2 at screening test Other protocol defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of unchanged form and metabolites | Up to 48 hours after dosing |
Countries
Japan
Contacts
Primary ContactTaisho Pharmaceutical Co., Ltd.
Outcome results
None listed