A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Ipragliflozin

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