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| ID | Type | Description | Link |
|---|---|---|---|
| J6M-MC-JSGC | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the safety and effect of food on LY4064809 and the safety and effect of stomach changes by a proton pump inhibitor (PPI) esomeprazole, under fasted conditions in healthy adult participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Treatment A Fasted | Experimental | LY4064809 administered orally |
|
| Group 1 Treatment B High-Fat Meal | Experimental | LY4064809 administered orally |
|
| Group 2 Treatment A Fasted | Experimental | LY4064809 administered orally |
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| Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect | Experimental | LY4064809 administered orally with esomeprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4064809 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809 | PK: Cmax of LY4064809 | Day 1 to Approximately Day 47 |
| Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time T (AUC 0-tlast) | PK: AUC 0-tlast, where t is the last time point with a measurable concentration | Day 1 to Approximately Day 47 |
| Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Zero to Infinity (AUCinf) | PK: AUCinf | Day 1 to Approximately Day 47 |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee), which may significantly alter the absorption, metabolism, or elimination of drugs, constitute a risk when taking the study intervention or interfere with the data interpretation:
Metabolic disease, including congenital non-hemolytic hyperbilirubinemia (for example, Gilbert syndrome),
Biliary disease, including cholecystectomy,
Gastrointestinal (GI) disease,
Hematological disease,
Neurological disease,
Significant history of, or presence of hepatic disease, including any abnormal liver function tests and serum total bilirubin above the 1.5
× upper limits of normal (ULN) range per the laboratory's reference ranges at screening or admission, or
Clinically significant, active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of LY4064809
History of a major surgical procedure within 30 days prior to screening
Diagnosed and/or treated malignancy within 5 years prior to screening with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and curatively resected in situ carcinoma of the cervix.
Have known allergies to LY4064809 or related compounds or esomeprazole or related compounds
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Pharmaron Clinical Pharmacology Center Inc | Baltimore | Maryland | 21201 | United States |
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