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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:
ClinicalTrials.gov Identifier:
NCT01187186
First Posted: August 23, 2010
Last Update Posted: October 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Astellas Pharma Inc
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 20, 2010
First Posted: August 23, 2010
Last Update Posted: October 7, 2010
Last Verified: October 2010

Keywords provided by Astellas Pharma Inc:
Liver disease
ASP1941

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases