To investigate the safety and tolerability of TC-5214 following oral administration of multiple doses for up to 8 days
Study identifier:D4130C00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Single Center, Double-blind, Randomized, Placebo- controlled, Parallel-group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TC-5214 (S-Mecamylamine) After Administration of Single and Multiple Ascending Doses for up to 8 Days in Healthy Male and Female Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
TC-5214, Placebo
Sex
All
Actual Enrollment
72
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Aug 2010
Study Completion Date: 01 Aug 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
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 Each cohort will have 9 volunteers that will receive TC-5214 | Drug: TC-5214 4 mg tablet, oral, BID, group 1 Drug: TC-5214 TBD tablet, oral, BID, groups 2-6 |
| Placebo Comparator: 2 Each cohort will have 3 volunteers that will receive placebo | - |
Contacts
Investigators
Principal Investigator
David Mathews
Quintiles
