Status:
COMPLETED
A Study of Food Effect and Esomeprazole on LY4064809 in Healthy Adult Participants
Lead Sponsor:
Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06991179
Start Date
May 20 2025
End Date
September 2 2025
Last Update
September 23 2025
Active Locations (1)
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1
Pharmaron Clinical Pharmacology Center Inc
Baltimore, Maryland, United States, 21201