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

Astellas

Status and phase: Completed; Phase 1

Conditions: Liver Disease

Treatments: Drug: ASP1941

Study type: Interventional

Funder types: Industry

Identifiers

NCT01187186

1941-CL-0063

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

16 participants in 2 patient groups

Moderate Hepatic Impairment

Experimental group

Description:

Subjects with Moderate Hepatic Impairment

Treatment:

Drug: ASP1941

Normal Hepatic Function

Experimental group

Description:

Subjects with Normal Hepatic Function

Treatment:

Drug: ASP1941