To investigate safety, tolerability and pharmacokinetics of TC-5214 in healthy male Japanese subjects
Study identifier:D4131C00002
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 study to assess the safety, tolerability and pharmacokinetics of a single dose and multiple doses of TC-5214 (S-Mecamylamine) in healthy male Japanese subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
TC-5214, Placebo
Sex
Male
Actual Enrollment
48
Study type
Interventional
Age
20 Years - 55 Years
Date
Study Start Date: 01 Jul 2010
Primary Completion Date: 01 Sept 2010
Study Completion Date: 01 Sept 2010
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: Active Each cohort will have 9 volunteers that will receive TC-5214 | Drug: TC-5214 Four increasing doses levels of a single dose and two increasing dose levels of 6 days repeated dose of TC-5214 tablet |
| Placebo Comparator: Placebo Each cohort will have 3 volunteers that will receive placebo | Drug: Placebo Placebo tablet, single dose and 6 days repeated dose |
Contacts
Investigators
Principal Investigator
Hans Eriksson
AstraZeneca R&D Sodertalje, SE-151 85 Sodertalje, Sweden
