Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: AZD3480 (Drug); Moxifloxacin (Drug); PLACEBO (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Hans-Göran Hårdemark, Study Director, Affiliation: Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
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.
Clinical Details
Official title: A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study
Primary outcome: 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
Secondary outcome: QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervalsPlasma concentration (AUC, Cmax, tmax etc) Registration of AEs, blood pressure, ECG, clinical laboratory tests
Eligibility
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
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.)
Locations and Contacts
Additional Information
Starting date: January 2008
Ending date: August 2008
Last updated: May 29, 2008
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