A study of single and multiple ascending doses of TC-5214 in Japanese healthy elderly male and female volunteers
Study identifier:D4131C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, single center, randomized, double-blind, placebo-controlled parallel-group study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of TC-5214 in Japanese healthy elderly male and female volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
TC-5214, Placebo
Sex
All
Actual Enrollment
48
Study type
Interventional
Age
65 Years +
Date
Study Start Date: 01 Jul 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: 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: TC-5214 | Drug: TC-5214 Tablet, Oral, twice daily |
| Placebo Comparator: Placebo | Drug: Placebo Tablet, Oral, twice daily |
Contacts
Investigators
Principal Investigator
Hans Eriksson
AstraZeneca
