Study identifier:D4130C00009
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A single-centre, randomised, double-blind, placebo controlled Phase I study in two parts: Part A to assess a safe and tolerable supratherapeutic dose of TC-5214 after single ascending oral doses in healthy male subjects, followed by Part B: A four-period double-dummy crossover study to investigate the effect of 2 single doses (therapeutic and supratherapeutic) of TC-5214 on the QT/QTc interval, compared to placebo, using moxifloxacin (Avelox®) as a positive control, in healthy male subjects
healthy male
Phase 1
Yes
TC-5214, Moxifloxacin
Male
16
Interventional
18 Years - 50 Years
Allocation: Randomized 
Endpoint Classification: Safety Study 
Intervention Model: Crossover Assignment 
Masking: Double Blind 
Primary Purpose: Basic Science 
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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No locations available
| Arms | Assigned Interventions | 
|---|---|
| Experimental: Part A 1 TC-5214 | Drug: TC-5214  Single dose, oral tablets | 
| Experimental: Part A 2 TC-5214 placebo | Other: Placebo comparator  Single dose, oral tablets | 
| Experimental: Part B 1 TC-5214 8 mg + moxifloxacin placebo | Drug: TC-5214  Single dose, oral tablets Other: Moxifloxacin placebo comparator  Single dose, oral encapsulated tablet | 
| Experimental: Part B 2 TC-5214 supratherapeutic dose + moxifloxacin placebo | Drug: TC-5214  Single dose, oral tablets Other: Moxifloxacin placebo comparator  Single dose, oral encapsulated tablet | 
| Active Comparator: Part B 3 TC-5214 placebo + moxifloxacin 400 mg | Other: Placebo comparator  Single dose, oral tablets Drug: Moxifloxacin  Single dose, oral encapsulated tablet Other Name: Avelox® | 
| Placebo Comparator: Part B 4 TC-5214 placebo + moxifloxacin placebo | Other: Placebo comparator  Single dose, oral tablets Other: Moxifloxacin placebo comparator  Single dose, oral encapsulated tablet |