A two-part single and multiple dose study to assess the safety , pharmacokinetics and effects of AZD3293 in healthy Japanese young and elderly volunteers
Study identifier:D5010C00003
ClinicalTrials.gov identifier:NCT02005211
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Healthy Japanese Male and Non-Fertile Female Volunteers including Elderly
Medical condition
Healthy Japanese young and elderly male and non-fertile female volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3293, Placebo
Sex
All
Actual Enrollment
114
Study type
Interventional
Age
20 Years - 80 Years
Date
Study Start Date: 01 Dec 2013
Primary Completion Date: 01 Jul 2014
Study Completion Date: 01 Jul 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Sept 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD3293 AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1. | 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
