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To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Each cohort will have 9 volunteers that will receive TC-5214 |
|
| 2 | Placebo Comparator | Each cohort will have 3 volunteers that will receive placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC-5214 | Drug | 4 mg tablet, oral, BID, group 1 |
| |
| TC-5214 |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical lab assessments, physical exams, neurological exams, suicidality evaluations, visual acuity tests and digital ECGs | Collected prior to treatment, during treatment and for 7-10 days following discharge. Volunteers will be monitored througout the study for adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics of TC-5214 in blood and urine after single and repeated oral doses by collecting blood and urine samples to measure drug concentration levels | Blood sampling, every in house day; urine collection ;Days -1 through Day 6, Days 8 through 11. | |
| To assess the effect of food on the pharmacokinetics of TC-5214 following oral administration by collecting blood and urine samples to measure drug concentration levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mathews, MD | Quintiles, Inc. | Principal Investigator |
| Donna Holloway | Quintiles, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24408516 | Derived | Xu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N. Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies. J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16. |
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| Drug |
TBD tablet, oral, BID, groups 2-6 |
|
| Placebo | Drug |
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| Samples taken during the residential period at defined timepoints pre-dose and post-dose |