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

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

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).

Study Overview

• Status: Completed
• Conditions: Liver Disease
• Intervention / Treatment: Drug: ASP1941

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Hepatic Impairment; Subjects with Moderate Hepatic Impairment	Drug: ASP1941; oral
Experimental: Normal Hepatic Function; Subjects with Normal Hepatic Function	Drug: ASP1941; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: August 20, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): October 7, 2010
• Last Update Submitted That Met QC Criteria: October 5, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: ASP1941; Liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Ipragliflozin
• Other Study ID Numbers: 1941-CL-0063