Clinical trial NCT01187186: A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
Official title: A Phase 1, Open-Label, Single-Dose Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Disease
Keywords: Liver disease
ASP1941
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-08-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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).

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 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

Primary outcomes:
measure: Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples
timeFrame: 7 days following study drug administration
Secondary outcomes:
measure: Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples
timeFrame: 7 days following study drug administration
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References: