Status:
COMPLETED
A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Liver Disease
Eligibility:
All Genders
18-69 years
Phase:
PHASE1
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 ...
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 clin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01187186
Start Date
May 1 2010
End Date
August 1 2010
Last Update
October 7 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Miami, Florida, United States, 33014