A Study of Food Effect and Esomeprazole on LY4064809 in Healthy Adult Participants

Launched by SCORPION THERAPEUTICS, A WHOLLY OWNED SUBSIDIARY OF ELI LILLY AND COMPANY · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a study drug called LY4064809 behaves in the body, especially when taken with food and after using a medication called esomeprazole, which is used to reduce stomach acid. The goal is to understand if eating food affects how the drug works and to check the safety of the drug in healthy adults. Participants will have blood tests done to see how their bodies process the drug and how it impacts their health.

To be part of this study, participants need to be healthy adults aged between 18 and 65 years, with normal blood pressure and body weight. They should not have any serious medical conditions that could affect how their body handles medications. The trial is not currently recruiting participants, but if you fit the eligibility criteria, you could be involved in an important research study that helps understand this new drug better. Participants can expect to attend appointments for health checks and blood tests during the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Are healthy as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations at screening and/or admission as assessed by the investigator (or designee)
• • Participants have normal blood pressure and pulse rate, as determined by the investigator
• • Have venous access sufficient to allow for blood sampling
• • Have a body mass index (BMI) within the range 18-32 kilogram/square meter (kg/m²) (inclusive)
• • Individuals not of childbearing potential and individuals assigned male at birth may participate in this trial
• 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