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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.
On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1, 2 and 3 ABBV-CLS-7262 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-CLS-7262 | Drug | ABBV-CLS-7262 |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food. | Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC) | Approximately Two Weeks |
| To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce. | Maximum Plasma Concentration [Cmax]; Area under the Curve (AUC) | Approximately Two Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Number of patients with treatment-related adverse events as assessed by NCI CTCAE v4.03 | Approximately Six Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AbbVie Clinical Pharmacology Research Unit (ACPRU) | Grayslake | Illinois | 60030 | United States |
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