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.”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: AZD3480
  • Capsule, oral, single dose, 6 days
• Drug: Moxifloxacin
  • Capsule(encapsulated), oral, single dose
• Drug: PLACEBO
  • Capsule, oral, single dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Escalating doses of AZD3480 during 6 days
• Experimental: 2
  • Repeated doses of AZD3480 during 6 days
• Placebo Comparator: 3
  • Placebo during 6 days
• Active Comparator: 4
  • Placebo during 5 days, active day 6

Primary Measures

• 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
  • Time Frame: 11 dECG measurements x 4 (4-way crossover)
    Safety Issue?: No

Secondary Measures

• QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals
  • Time Frame: 11 dECG measurements x 4 (4-way crossover)
    Safety Issue?: Yes
• Plasma concentration (AUC, Cmax, tmax etc)
  • Time Frame: 11 PK-measurements x 4 (4-way crossover)
    Safety Issue?: Yes
• Registration of AEs, blood pressure, ECG, clinical laboratory tests
  • Time Frame: From enrolment to follow-up
    Safety Issue?: Yes

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.)

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Hans-Göran Hårdemark Study Director Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00686179

Study ID Number: D3690C00004

ClinicalTrials.gov Identifier: NCT00686179

Health Authority: Sweden: Medical Products Agency