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Completed

NCT Number: NCT01187186

A 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).

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, 33014, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP1941

Drug

oral

Primary outcomes

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

    Time frame: 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

    Time frame: 7 days following study drug administration

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 23, 2010
Registry last updated
Oct 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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