NCT01359618

Determining Highest Dose Administration of TC-5214 and Evaluating Effect on the Electrical Activity in the Heart

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a two part study. Part A will determine the maximum tolerated dose of TC-5214 administered to healthy male subjects in single ascending oral doses. This part of the study will define the highest dose of TC-5214 to be administered in Part B. Part B of this study will investigate the effect of TC-5214 on the electrical activity of the heart following single oral administration. The study will be carried out healthy male subjects in a four period crossover study with TC-5214 compared to placebo and oral moxifloxacin as a positive control. The safety, tolerability and pharmacokinetics of TC-5214 will also be evaluated.

Conditions

• Healthy Male

Interventions

Type	Name	Description
DRUG	TC-5214	Single dose, oral tablets
OTHER	Placebo comparator	Single dose, oral tablets
DRUG	Moxifloxacin	Single dose, oral encapsulated tablet
OTHER	Moxifloxacin placebo comparator	Single dose, oral encapsulated tablet

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-05-25
• Last updated: 2012-12-12

Locations

1 site across 1 country: United Kingdom