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The objectives of this study are to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple doses of ABT-436 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose ABT-436 | Experimental | ABT-436 or placebo administered once daily for 7 days. |
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| Mid Dose ABT-436 | Experimental | ABT-436 or placebo administered once daily for 7 days. |
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| High Dose ABT-436 | Experimental | ABT-436 or placebo administered once daily for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-436 | Drug | See Arm Description for details. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Assessments (i.e., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations) | Days -2 through Day 7 or 14 | |
| Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels) | Day -1 through Day 7 | |
| Pharmacodynamics (i.e., biomarkers of drug effect) | Day -1 through Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 24849 | Waukegan | Illinois | 60085 | United States |
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| Placebo | Drug | See Arm Description for details. |
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