AZD3293 Thorough QT study in healthy male volunteers - AZD3293TQT
Study identifier:D5010C00008
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects
Medical condition
Alzheimer's disease
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3293, Placebo, Moxifloxacin
Sex
Male
Actual Enrollment
52
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jan 2014
Primary Completion Date: 01 May 2014
Study Completion Date: 01 May 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
PAREXEL
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD3293 dose A AZD3293 therapeutic dose oral solution (low dose) | Drug: AZD3293 AZD3293 oral solution - one single dose (low dose). Other Name: beta secretase inhibitor |
| Experimental: AZD3293 dose B AZD3293 supratherapeutic dose oral solution (high dose) | Drug: AZD3293 AZD3293 oral solution - one single dose (high dose). Other Name: Not applicable |
| Placebo Comparator: Placebo Placebo oral solution | Drug: Placebo Placebo oral solution - one single dose Other Name: Not applicable |
| Active Comparator: Moxifloxacin Moxifloxacin tablet | Drug: Moxifloxacin Moxifloxacin tablet - one single dose Other Name: Not applicable |
Investigators
Principal Investigator
Ronald Goldwater
Parexel ECPU Baltimore
