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

Completed · Phase 1

Conditions studied: Liver Disease

In brief

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).

Key facts

Study ID: NCT01187186
Run by: Astellas Pharma Inc
People needed: 16
Starts: 2010-05-01
Expected to finish: 2010-08-01
Last updated by the study team: 2010-10-07

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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