Status:
COMPLETED
Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer
Eligibility Criteria
Inclusion
- Non Smoker
- 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 :
November 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00713336
Start Date
June 1 2008
End Date
November 1 2008
Last Update
September 28 2010
Active Locations (1)
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1
Research Site
Macclesfield, United Kingdom