Study in Healthy Subjects to Measure the Effects of Food on the Pharmacokinetics of TC-5214

Study Overview
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Brief Summary
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(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.

Detailed Description
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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

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: TC-5214


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed, written, and dated informed consent prior to any study specific procedures. Healthy male and nonpregnant, nonlactating female 18 to 55 years, inclusive, with suitable veins for cannulation or repeated venipuncture. Have a body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg Be willing to eat the high-calorie, high-fat breakfast or fast accordingly Be able to understand and comply with the requirements of the study as judged by the Investigator Exclusion Criteria: History of any clinically significant medical, neurologic, or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor, may either put the volunteer at risk because of participation in the study, or influence the results History of gastrointestinal surgery (except for appendectomy) or unintentional rapid weight loss History of seizure activity, including febrile seizures Past diagnosis of more than 1 episode of major depression History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - first fed then fasted treatment<br>TC-5214 | Drug: TC-5214<br>* Oral tablets, single 4mg dose<br>|
| Experimental: B - first fasted then fed treatment<br>TC-5214 | Drug: TC-5214<br>* Oral tablets, single 4mg dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TC-5214 area under the plasma concentration time curve will be measured. |  | 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 |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with adverse events |  | During day - 1, day 1, 2, 3 and 4 of treatment period | 
| A change from baseline in laboratory assessments |  | During day - 1 and day 3 of visits 2 and 3 of treatment period | 
| A change from baseline in vital signs |  | During day - 1, day 1, 2, 3 and 4 of treatment period | 
| A change from baseline in physical examination |  | 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 |  | 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 |  | PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, healthy male, nonpregnant female, volunteers, pharmacokinetics, TC 5214, The effect of food on the pharmacokinetics of TC-5214