Status:
COMPLETED
Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets.
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This study is designed to see how different formulations of ZD4054 (Zibotentan) are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.
Eligibility Criteria
Inclusion
- Normal resting 12-lead ECG with normal QTc interval (\<450 msec)
- Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening
Exclusion
- Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
- Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
- Judgement by the investigator, that the healthy volunteer should not participate in the study
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00713791
Start Date
June 1 2008
End Date
August 1 2008
Last Update
November 15 2010
Active Locations (1)
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1
Research Site
Philadelphia, Pennsylvania, United States