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The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose ABT-384 | Experimental |
| |
| Mid dose ABT-384 | Experimental |
| |
| High dose ABT-384 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-384 | Drug | 3 escalating doses will be administered daily for 21 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) | Days -2 through 84 | |
| Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect) | Days -1 through 27 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 23024 | Orlando | Florida | 32809 | United States |
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| ID | Term |
|---|---|
| C584004 | N-(5-(aminocarbonyl)tricyclo(3.3.1.13,7)dec-2-yl)-alpha,alpha-dimethyl-4-(5-(trifluoromethyl)-2-pyridinyl)-1-piperazineacetamide |
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| Matching placebo to ABT-384 | Drug | Doses will be administered daily for 21 days |
|