Healthy Subjects
Conditions
Keywords
Phase 1, healthy male, nonpregnant female, volunteers, pharmacokinetics, TC 5214, The effect of food on the pharmacokinetics of TC-5214
Brief summary
(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.
Detailed description
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
Interventions
DRUGTC-5214
Oral tablets, single 4mg dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| The number of participants with adverse events | During day - 1, day 1, 2, 3 and 4 of treatment period |
| 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 |
| 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 |
| A change from baseline in laboratory assessments | During day - 1 and day 3 of visits 2 and 3 of treatment period |
Countries
United States
Outcome results
None listed