Pharmacokinetics, Safety & Tolerability of ZD4054 (Zibotentan) in Subjects With Normal, Mild, Moderate and Severe Hepatic Impairment

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: ZD4054

Study type: Interventional

Funder types: Industry

Identifiers

NCT00672581

4054IL/0025

D4320C00025

Details and patient eligibility

About

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 subjects of a similar age, sex and weight. As for all clinical trials, safety and tolerability of the drug will be evaluated as well to develop dosing recommendations for dosing of ZD4054 (Zibotentan) in subjects with varying stages of hepatic impairment.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

1

Experimental group

Description:

Control (healthy volunteers)

Treatment:

Drug: ZD4054

2

Experimental group

Description:

Mild Hepatic Impairment

Treatment:

Drug: ZD4054

3

Experimental group

Description:

Moderate Hepatic Impairment

Treatment:

Drug: ZD4054

4

Experimental group

Description:

Severe Hepatic Impairment

Treatment:

Drug: ZD4054