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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01187186
First received: August 20, 2010
Last updated: October 5, 2010
Last verified: October 2010
History of Changes
  Purpose

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).


Condition Intervention Phase
Liver Disease
 Drug: ASP1941
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase 1, Open-Label, Single-Dose Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples [ Time Frame: 7 days following study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples [ Time Frame: 7 days following study drug administration ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate Hepatic Impairment
Subjects with Moderate Hepatic Impairment
 Drug: ASP1941
oral
Experimental: Normal Hepatic Function
Subjects with Normal Hepatic Function
 Drug: ASP1941
oral

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187186

Locations
United States, Florida
Miami, Florida, United States, 33014
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01187186     History of Changes
Other Study ID Numbers: 1941-CL-0063
Study First Received: August 20, 2010
Last Updated: October 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Liver disease
ASP1941

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 17, 2012