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

NCT01187186 | Completed Phase 1

• 1 other identifier: 1941-CL-0063
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Disease

Keywords

Liver disease; ASP1941

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples

  7 days following study drug administration

Secondary Outcomes (1)

• Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples

  7 days following study drug administration

Study Arms (2)

Moderate Hepatic Impairment

EXPERIMENTAL

Subjects with Moderate Hepatic Impairment

Drug: ASP1941

Normal Hepatic Function

EXPERIMENTAL

Subjects with Normal Hepatic Function

Drug: ASP1941

Interventions

ASP1941 DRUG

oral

Moderate Hepatic Impairment; Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Miami, Florida, 33014, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

ipragliflozin

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Use Central Contact

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 23, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 7, 2010

Record last verified: 2010-10

Locations

US (1)