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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD3480; Drug: PLACEBO; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00686179

D3690C00004

EUdract NO 2007-004859-11

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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75 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Escalating doses of AZD3480 during 6 days

Treatment:

Drug: AZD3480

2

Experimental group

Description:

Repeated doses of AZD3480 during 6 days

Treatment:

Drug: AZD3480

3

Placebo Comparator group

Description:

Placebo during 6 days

Treatment:

Drug: PLACEBO

4

Active Comparator group

Description:

Placebo during 5 days, active day 6

Treatment:

Drug: Moxifloxacin