Pharmacokinetics, Safety & Tolerability of ZD4054 (Zibotentan) in Subjects with Normal, Mild, Moderate and Severe Hepatic Impairment
Study identifier:D4320C00025
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-label Comparative Study of the Pharmacokinetics, Safety and Tolerability of ZD4054 (Zibotentan) following a 10 mg Single Oral Dose of ZD4054(Zibotentan) to Healthy Subjects and to Subjects with Mild, Moderate and Severe Hepatic Impairment
Medical condition
Hepatic Impairment
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ZD4054
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Apr 2008
Primary Completion Date: -
Study Completion Date: 01 Mar 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
PRA International
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Control (healthy volunteers) | Drug: ZD4054 10mg, Oral tablet, single dose Other Name: Zibotentan |
| Experimental: 2 Mild Hepatic Impairment | Drug: ZD4054 10mg, Oral tablet, single dose Other Name: Zibotentan |
| Experimental: 3 Moderate Hepatic Impairment | Drug: ZD4054 10mg, Oral tablet, single dose Other Name: Zibotentan |
| Experimental: 4 Severe Hepatic Impairment | Drug: ZD4054 10mg, Oral tablet, single dose Other Name: Zibotentan |
Contacts
Investigators
Principal Investigator
Thomas Morris
AstraZeneca, Medical Science Director
