A single dose study to assess the safety, effects, and blood and urine drug levels of AZD3293 in healthy subjects
Study identifier:D5010C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
Medical condition
Healthy young volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3293, Placebo
Sex
All
Actual Enrollment
72
Study type
Interventional
Age
18 Years - 80 Years
Date
Study Start Date: 01 Dec 2012
Primary Completion Date: 01 May 2013
Study Completion Date: 01 May 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Aug 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD3293 Up to 11 sequential cohorts of healthy young and healthy elderly subjects are planned, with single ascending doses ranging from 1mg to a maximum of 1000mg | Drug: AZD3293 Oral solution |
| Placebo Comparator: Placebo Placebo given (2 subjects in each cohort) | Drug: Placebo Oral solution |
Contacts
Investigators
Principal Investigator
Robert C Alexander
AstraZeneca
