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