(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.
Phase I, Open-label, Randomized, Single-dose, Two treatment (Fed Versus Fasted) Crossover Study to Assess the Effects of Food on the Pharmacokinetics of TC-5214 (S-Mecamylamine) in Healthy Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Oral tablets, single 4mg dose
Research Site
Overland Park, Kansas, United States
TC-5214 area under the plasma concentration time curve will be measured.
Time frame: Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose
TC-5214 maximum plasma concentration will be measured
Time frame: Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose
The number of participants with adverse events
Time frame: During day - 1, day 1, 2, 3 and 4 of treatment period
A change from baseline in laboratory assessments
Time frame: During day - 1 and day 3 of visits 2 and 3 of treatment period
A change from baseline in vital signs
Time frame: During day - 1, day 1, 2, 3 and 4 of treatment period
A change from baseline in physical examination
Time frame: During day -1
Description of the pharmacokinetics (PK) of TC-5214 in terms of area under the curve over the time (AUC) and maximum concentration (Cmax) and terminal half-life
Time frame: PK samles collected at pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose
Description of urine pharmacokinetics (PK) of TC-5214 in terms of the cumulative amount of drug excreted unchanged into urine from zero to time and renal clearance
Time frame: PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose
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