Investigate the Effect on the QT/QTc interval of Repeated and Escalating Doses of AZD3480 during 6 Days - TQT
Study identifier:D3690C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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.
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3480, Moxifloxacin, PLACEBO
Sex
Male
Actual Enrollment
75
Study type
Interventional
Age
20 Years - 60 Years
Date
Study Start Date: 01 Jan 2008
Primary Completion Date: 01 Aug 2008
Study Completion Date: 01 Aug 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Escalating doses of AZD3480 during 6 days | Drug: AZD3480 Capsule, oral, single dose, 6 days Other Name: TC-1734-226 |
| Experimental: 2 Repeated doses of AZD3480 during 6 days | Drug: AZD3480 Capsule, oral, single dose, 6 days Other Name: TC-1734-226 |
| Placebo Comparator: 3 Placebo during 6 days | Drug: PLACEBO Capsule, oral, single dose |
| Active Comparator: 4 Placebo during 5 days, active day 6 | Drug: Moxifloxacin Capsule(encapsulated), oral, single dose Other Name: Moxifloxacin |
Contacts
Investigators
Principal Investigator
Hans-Göran Hårdemark
Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
