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| ID | Type | Description | Link |
|---|---|---|---|
| J4C-OX-JZUC | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Loxo Oncology, Inc. | INDUSTRY |
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The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered in fasting and fed states in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783. Participation could last up to 63 days including screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOXO-783 (Fasted State) | Experimental | LOXO-783 administered orally to participants who are in fasted state |
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| LOXO-783 (Fed State - Low Fat Meal) | Experimental | LOXO-783 administered orally to participants who are on low fat meal |
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| LOXO-783 (Fed State - High Fat Meal) | Experimental | LOXO-783 administered orally to participants who are on high fat meal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOXO-783 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783 | PK: Cmax of LOXO-783 | Predose on Day 1 up to 96 hours postdose |
| PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783 | PK: AUC [0-∞] of LOXO-783 | Predose on Day 1 up to 96 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingying Guo-Avrutin, MD, PhD | Loxo Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Daytona Beach | Florida | 32117 | United States |
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