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

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187186
• Other study ID #: 1941-CL-0063
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2010
• Last updated: October 5, 2010
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: October 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Drug:
• ASP1941
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples		7 days following study drug administration	No
Secondary	Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples		7 days following study drug administration	No