Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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.)