Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days
- Registration Number
- NCT00686179
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 75
Inclusion Criteria
- Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
- Physically and mentally healthy male volunteers
Exclusion Criteria
- History of clinically significant diseases or illness.
- Participation in another study the last 3 months
- Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 AZD3480 Escalating doses of AZD3480 during 6 days 2 AZD3480 Repeated doses of AZD3480 during 6 days 3 PLACEBO Placebo during 6 days 4 Moxifloxacin Placebo during 5 days, active day 6
- Primary Outcome Measures
Name Time Method QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3 11 dECG measurements x 4 (4-way crossover)
- Secondary Outcome Measures
Name Time Method QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals 11 dECG measurements x 4 (4-way crossover) Plasma concentration (AUC, Cmax, tmax etc) 11 PK-measurements x 4 (4-way crossover) Registration of AEs, blood pressure, ECG, clinical laboratory tests From enrolment to follow-up