Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects
Study identifier:D2080C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Single-centre, Randomised, Double-blind, Placebo-controlled Parallel group Study to Assess the Safety, Tolerability and Pharmacokinetics after Oral Single Ascending Doses of AZD2516 in Young and Elderly Japanese Healthy Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD2516, Placebo
Sex
All
Actual Enrollment
40
Study type
Interventional
Age
20 Years - 80 Years
Date
Study Start Date: 01 Sept 2009
Primary Completion Date: 01 Dec 2009
Study Completion Date: 01 Dec 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Capsule administered once orally | Drug: AZD2516 Capsule administered once orally. Specific dose depends on dose panel. |
| Placebo Comparator: 2 Capsule administered once orally | Drug: Placebo Capsule administered once orally |
Contacts
Investigators
Principal Investigator
Anders Neijber
AstraZeneca R&D Södertälje
