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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
16
Single dose, oral tablets
Single dose, oral tablets
Single dose, oral encapsulated tablet
Single dose, oral encapsulated tablet
Research Site
London, United Kingdom
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: The number of participants with adverse events
Time frame: Up to 24 hours
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: A change from baseline in laboratory assessments.
Time frame: Up to 24 hours
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: A change from baseline in vital signs.
Time frame: Up to 24 hours
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: A change from baseline in electrocardiogram (ECG).
Time frame: Up to 24 hours
Part A: To examine the safety and tolerability of TC-5214. The following assessments will be measured and reported: A change from baseline in physical examination.
Time frame: Up to 24 hours
Part B: The maximum mean change in time-matched ECG interval, measured from the onset of the QRS complex to the T point, using the best heart rate correction method (QTc).
Time frame: Up to 24 hours
Part A: TC-5214 Plasma and urine pharmacokinetic variable to be measured: including, C max, time to C max, Area Under Curve (AUC) (0-t), terminal half life, cumulative amount of drug excreted unchanged into urine from zero to time and renal clearance
Time frame: Up to 72 Hours
Part B: A change in the maximum of the mean change in time-matched ECG interval, measured from the onset of the QRS complex
Time frame: Up to 24 Hours
Part B: Assay sensitivity by measuring the effect of moxifloxacin 400 mg on QTc compared to placebo
Time frame: Up to 24 hours
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