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| ID | Type | Description | Link |
|---|---|---|---|
| I3O-MC-JSBH | Other Identifier | Eli Lilly and Company. |
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The purpose of this study is to evaluate the effect of food on merestinib (standard meal and high-fat meal) compared to the fasted state. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In addition, the tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last approximately 28 days. Screening is required within 28 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Merestinib Fasted | Experimental | Single dose of merestinib administered in fasted state in one of three periods |
|
| Merestinib Standard Meal | Experimental | Single dose of merestinib administered with a standard meal in one of three periods |
|
| Merestinib High-Fat Meal | Experimental | Single dose of merestinib administered with a high-fat meal in one of three periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Merestinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) for Merestinib for High-Fat Meal and Fasted State | Predose through 120 hours after administration of study drug | |
| Pharmacokinetics: Maximum Concentration (Cmax) for Merestinib for Standard Meal and Fasted State | Predose through 120 hours after administration of study drug | |
| Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State | Predose through 120 hours after administration of study drug | |
| Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for Standard Meal and Fasted State | Predose through 120 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State | Predose through 120 hours after administration of study drug | |
| Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for Standard Meal and Fasted State |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| C586252 | merestinib |
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| Predose through 120 hours after administration of study drug |
| Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State | Predose through 120 hours after administration of study drug |
| Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for Standard Meal and Fasted State | Predose through 120 hours after administration of study drug |