Miami, Florida, 33014, United States
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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Conditions
Age range
18 year–69 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
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
Drugoral
Primary outcomes
-
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
-
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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