Liver Disease
Conditions
Keywords
Liver disease, ASP1941
Brief summary
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the Child-Pugh Classification (CPC).
Detailed description
Study drug will be orally administered on Day 1. Subjects will be admitted to the clinic until completion of clinic discharge procedures on Day 7 with an outpatient follow-up visit 6-9 days after clinic discharge.
Interventions
DRUGASP1941
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects with Moderate Hepatic Impairment * Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating * Weights at least 45 kg * Body mass index between 18 and 34 kg/m2 * Meets criteria for moderate hepatic impairment defined by Child-Pugh method * Subjects with Normal Hepatic Function * Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating * Weights at least 45 kg * Body mass index between 18 and 34 kg/m2 * Must have normal hepatic function defined by Child-Pugh method
Exclusion criteria
* Subjects with Moderate Hepatic Impairment * Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced ascites, portal hypertension, esophageal /gastric variceal bleeding, hepatocellular carcinoma, previous liver transplantation. * Has severe or moderate renal dysfunction * Known to be human immunodeficiency virus (HIV) positive * Has clinically significant history or presence of illness, malignancy or immunodeficiency * Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in * Has history of alcoholism or drug/chemical/substance abuse within past 2 years * Subjects with Normal Hepatic Function * Has severe or moderate renal dysfunction * Known to be human immunodeficiency virus (HIV) positive * Has clinically significant history or presence of illness, malignancy or immunodeficiency * Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in * Has history of alcoholism or drug/chemical/substance abuse within past 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples | 7 days following study drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples | 7 days following study drug administration |
Countries
United States
Outcome results
None listed