Determining highest dose administration of TC-5214 and evaluating effect on the electrical activity in the heart
Study identifier:D4130C00009
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
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
Medical condition
healthy male
Phase
Phase 1
Healthy volunteers
Yes
Study drug
TC-5214, Moxifloxacin
Sex
Male
Actual Enrollment
16
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 Jun 2011
Primary Completion Date: 01 Apr 2012
Study Completion Date: 01 Apr 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover 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: 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 |
Contacts
Investigators
Principal Investigator
Hans A Eriksson
AstraZeneca Pharmaceuticals
