Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00713336
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 4 ZD4054 Placebo ZD4054 Placebo + Moxifloxacin placebo 4 ZD4054 ZD4054 Placebo + Moxifloxacin placebo 2 ZD4054 ZD4054 placebo + Moxifloxacin 4 Moxifloxacin placebo ZD4054 Placebo + Moxifloxacin placebo 2 Moxifloxacin ZD4054 placebo + Moxifloxacin 3 ZD4054 Placebo ZD4054 + ZD4054 placebo + Moxifloxacin placebo 3 Moxifloxacin placebo ZD4054 + ZD4054 placebo + Moxifloxacin placebo 1 ZD4054 ZD4054 + Moxifloxacin placebo 1 Moxifloxacin placebo ZD4054 + Moxifloxacin placebo 2 ZD4054 Placebo ZD4054 placebo + Moxifloxacin 3 ZD4054 ZD4054 + ZD4054 placebo + Moxifloxacin placebo
- Primary Outcome Measures
Name Time Method to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
- Secondary Outcome Measures
Name Time Method assess the maximum of mean changes in time-matched QTcX, QT, QTcB, QTcF and QTcI intervals after moxifloxacin administration compared to placebo. Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h assess the maximum of the mean changes in time-matched QT, QTcB (Bazett's correction), QTcF (Fridericia's correction) and QTcI (subject specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h further assess the safety and tolerability of ZD4054 (Zibotentan) by assessment of adverse events (AEs), laboratory variables and vital signs. From time of Consent to Last Follow-up Visit
Trial Locations
- Locations (1)
Research Site
🇬🇧Macclesfield, United Kingdom