Status:
COMPLETED
Pharmacokinetics, Safety & Tolerability of ZD4054 (Zibotentan) in Subjects With Normal, Mild, Moderate and Severe Hepatic Impairment
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
PRA Health Sciences
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to healthy subje...
Eligibility Criteria
Inclusion
- Hepatically impaired subjects - Subjects with stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study.
- Healthy volunteers - Clinical laboratory tests within the normal reference range or results with minor deviations which are not considered by the Investigator to be clinically significant
Exclusion
- In the opinion of the investigator, any evidence of additional severe or uncontrolled systemic disease (eg, cardiac, or renal disease) or evidence of any other significant clinical disorder or laboratory finding
- Healthy volunteers - History or presence of hepatic disease known to interfere with absorption, distribution, metabolism or excretion of drug
- Hepatically impaired subjects - Fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00672581
Start Date
April 1 2008
End Date
March 1 2009
Last Update
September 28 2010
Active Locations (1)
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1
Research Site
Prague, Czechia