drugset / Trial / NCT01254448
Multiple Ascending Dose Study of TC-5619 in Healthy Elderly Subjects and Subjects With Alzheimer's Disease
RandomizedSingle-groupTriple-blindDiagnostic
Summary
This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.
Timeline
- Start
- 2010-09
- Primary completion
- 2011-03
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bradanicline | Small molecule | 25 mg | Oral |
| Subject | Bradanicline | Small molecule | 50 mg | Oral |
| Subject | Bradanicline | Small molecule | 150 mg | Oral |