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| ID | Type | Description | Link |
|---|---|---|---|
| J4C-OX-JZUD | 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 conduct blood tests to measure how much LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered alone or in combination with cholestyramine in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783 with and without cholestyramine. Participation could last up to 63 days including screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOXO-783 alone | Experimental | Single dose of LOXO-783 administered orally. |
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| LOXO-783 + Cholestyramine 1 hour post dose | Experimental | Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 1 hour. |
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| LOXO-783 + Cholestyramine 4 hours post dose | Experimental | Single dose of LOXO-783 administered orally followed by a single dose of cholestyramine administered orally after 4 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOXO-783 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783 | PK: Cmax of LOXO-783 | Predose on Day 1 upto 96 hours postdose of each treatment period |
| PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LOXO-783 | PK: AUC(0-inf) of LOXO-783 | Predose on Day 1 upto 96 hours postdose of each treatment period |
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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 |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D002792 | Cholestyramine Resin |
| ID | Term |
|---|---|
| D011137 | Polystyrenes |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Cholestyramine | Drug | Administered orally. |
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| D001697 |
| Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |