A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Moderate Hepatic Impairment Subjects with Moderate Hepatic Impairment |
Drug: ASP1941
oral
|
| Experimental: Normal Hepatic Function Subjects with Normal Hepatic Function |
Drug: ASP1941
oral
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples [7 days following study drug administration]
Secondary Outcome Measures
- Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples [7 days following study drug administration]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miami | Florida | United States | 33014 |
Sponsors and Collaborators
- Astellas Pharma Inc
Investigators
- Study Director: Use Central Contact, Astellas Pharma Global Development
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1941-CL-0063