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| ID | Type | Description | Link |
|---|---|---|---|
| I9Y-OX-JDHE | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Loxo Oncology, Inc. | INDUSTRY |
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The main purpose of study is to compare different formulations of LY3410738 under fasting condition by looking at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. The study will also access the effect of standard low-fat meal and esomeprazole (Proton Pump Inhibitor) on LY3410738. Safety and tolerability of LY3410738 will also be evaluated. For each participant, the total duration of the study will be 56 days for Groups 1 and 2 and up to 61 days for Groups 3 and 4, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Tablet versus Capsule | Experimental | Treatment A: LY3410738 capsule on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment B: LY3410738 tablet on Day 4 as a single oral dose in the morning 10 hours prior to and 4 hours after dosing. |
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| Group 2: Food Effect Comparison Group | Experimental | Treatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment C: LY3410738 table on Day 4 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal. |
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| Group 3: Potential of Hydrogen (pH) Effect Fasted Group | Experimental | Treatment B: LY3410738 table on Day 1 as a single oral dose in the morning following a fast of at least 10 hours prior to and 4 hours after dosing. Treatment D: Esomeprazole single oral dose once daily (QD) in the morning on Days 4 through 8 in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole a single oral dose followed by LY3410738 tablet as a single oral dose in the morning, following a fast of at least 10 hours prior to and 4 hours after esomeprazole and LY3410738 coadministration. |
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| Group 4: pH Effect Fed Group | Experimental | Treatment C: LY3410738 table on Day 1 as a single oral dose in the morning 30 minutes after starting a standard low-fat meal. Treatment E: Esomeprazole as a single oral dose QD in the morning on Days 4 through 8, in fasted state followed by a standard low-fat meal. On Day 9, Esomeprazole as a single oral dose followed by a LY3410738 tablet in the morning in fed state standard low-fat meal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3410738 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-tlast) of LY3410738 Tablets Versus Capsules | PK: AUC0-tlast of LY3410738 Tablets Versus Capsules | Predose up to 48 hours postdose |
| PK: Area Under the Concentration from Hour 0 Extrapolated to Infinity (AUC0-∞) of LY3410738 Tablets Versus Capsules | PK: AUC0-∞ of LY3410738 Tablets Versus Capsules | Predose up to 48 hours postdose |
| PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 Tablets Versus Capsules | PK: Cmax of LY3410738 Tablets Versus Capsules | Predose up to 48 hours postdose |
| PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal | PK: AUC0-tlast of LY3410738 After Standard Low-Fat Meal | Predose up to 48 hours postdose |
| PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal | PK: AUC0-∞ of LY3410738 After Standard Low-Fat Meal | Predose up to 48 hours postdose |
| PK: Cmax of LY3410738 After Standard Low-Fat Meal | PK: Cmax of LY3410738 After Standard Low-Fat Meal | Predose up to 48 hours postdose |
| PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State | PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fasted State |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingying Guo-Avrutin | Loxo Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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Groups 1 and 2 have a randomized, 2-way crossover design and Groups 3 and 4 have a fixed-sequence design.
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| Esomeprazole | Drug | Administered orally. |
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| Predose up to 48 hours postdose |
| PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State | PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fasted State | Predose up to 48 hours postdose |
| PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State | PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fasted State | Predose up to 48 hours postdose |
| PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State | PK: AUC0-tlast of LY3410738 after Esomeprazole oral dose in the Fed State | Predose up to 48 hours postdose |
| PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State | PK: AUC0-∞ of LY3410738 after Esomeprazole oral dose in the Fed State | Predose up to 48 hours postdose |
| PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State | PK: Cmax of LY3410738 after Esomeprazole oral dose in the Fed State | Predose up to 48 hours postdose |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |