drugset / Trial / NCT01359618
Determining Highest Dose Administration of TC-5214 and Evaluating Effect on the Electrical Activity in the Heart
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | dexmecamylamine | Other / unclassified | 8 mg | Oral |
Indications
No indication recorded.