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

Phase 1

Completed

• Conditions: Liver Disease
• Interventions: Drug: ASP1941

• Registration Number: NCT01187186
• Lead Sponsor: Astellas Pharma Inc

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).

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 Timeline

• Study Start: 2010-05
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-05
• Last Update Posted: 2010-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Hepatic Impairment	ASP1941	Subjects with Moderate Hepatic Impairment
Normal Hepatic Function	ASP1941	Subjects with Normal Hepatic Function

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples	7 days following study drug administration

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples	7 days following study drug administration