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

NCT ID: NCT00686179

Last Updated: 2008-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Healthy

Keywords

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TQT ECG QT QTc AZD3480 ECG(QTc effects)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Escalating doses of AZD3480 during 6 days

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

Capsule, oral, single dose, 6 days

2

Repeated doses of AZD3480 during 6 days

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

Capsule, oral, single dose, 6 days

3

Placebo during 6 days

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

Capsule, oral, single dose

4

Placebo during 5 days, active day 6

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Capsule(encapsulated), oral, single dose

Interventions

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AZD3480

Capsule, oral, single dose, 6 days

Intervention Type DRUG

Moxifloxacin

Capsule(encapsulated), oral, single dose

Intervention Type DRUG

PLACEBO

Capsule, oral, single dose

Intervention Type DRUG

Other Intervention Names

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TC-1734-226

Eligibility Criteria

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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.)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D, Södertälje, Sweden

Principal Investigators

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Hans-Göran Hårdemark

Role: STUDY_DIRECTOR

Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden

Other Identifiers

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EUdract NO 2007-004859-11

Identifier Type: -

Identifier Source: secondary_id

D3690C00004

Identifier Type: -

Identifier Source: org_study_id