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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
August 20, 2010
August 23, 2010
October 7, 2010
May 2010
August 2010   (Final data collection date for primary outcome measure)
Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples [ Time Frame: 7 days following study drug administration ]
Same as current
Complete list of historical versions of study NCT01187186 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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 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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Liver Disease
Drug: ASP1941
oral
  • Experimental: Moderate Hepatic Impairment
    Subjects with Moderate Hepatic Impairment
    Intervention: Drug: ASP1941
  • Experimental: Normal Hepatic Function
    Subjects with Normal Hepatic Function
    Intervention: Drug: ASP1941
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01187186
1941-CL-0063
No
Not Provided
Not Provided
Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
Astellas Pharma Inc
Not Provided
Study Director: Use Central Contact Astellas Pharma Global Development
Astellas Pharma Inc
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP