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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1, Open-Label, Single-Dose Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941

Conditions
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Liver Disease

Intervention / Treatment
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* Drug: ASP1941


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Hepatic Impairment<br>Subjects with Moderate Hepatic Impairment | Drug: ASP1941<br>* oral<br>|
| Experimental: Normal Hepatic Function<br>Subjects with Normal Hepatic Function | Drug: ASP1941<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples |  | 7 days following study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples |  | 7 days following study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver disease, ASP1941