Overview

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

Status:
Terminated
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
AstraZeneca
Treatments:
Fluoroquinolones
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination