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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - first fed then fasted treatment | Experimental | TC-5214 |
|
| B - first fasted then fed treatment | Experimental | TC-5214 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC-5214 | Drug | Oral tablets, single 4mg dose |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans A Eriksson, MD | AstraZeneca Kvambergagatan 12, 15185, Sodertalje, Sweden | Study Chair |
| David Mathews, MD | Quintiles, Inc. Overland Park US | Principal Investigator |
| Brendan Smyth, MD | AstraZeneca 180 Concord Pike Wilmington, DE 19850-5437 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| 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 |