drugset / Trial / NCT01359618

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

NCT01359618

Phase 1 Terminated 16 enrolled AstraZeneca
RandomizedCrossoverDouble-blindBasic science

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.

Timeline

Start
2011-06
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Moxifloxacin Small molecule 400 mg Oral
Subject dexmecamylamine Other / unclassified 8 mg Oral

Indications

No indication recorded.