Assess the safety, tolerability and pharmacokinetics of AZD5213 after single and multiple ascending oral doses in healthy young and elderly Japanese subjects
Study identifier:D3030C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 after Oral Administration of Single and Multiple Ascending Doses in Healthy Young and Elderly J
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD5213, Placebo
Sex
All
Actual Enrollment
48
Study type
Interventional
Age
20 Years - 80 Years
Date
Study Start Date: 01 Apr 2011
Primary Completion Date: 01 Oct 2011
Study Completion Date: 01 Oct 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active Each cohort will have 6 subjects that will receive AZD5213 | Drug: AZD5213 Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days |
| Placebo Comparator: Placebo Each cohort will have 2 subjects that will receive placebo | Drug: Placebo Placebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days |
Contacts
Investigators
Principal Investigator
Märta Segerdahl
AstraZeneca R&D, Södertälje
