Healthy
Conditions
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 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.
Interventions
DRUGLY4064809
Administered orally
Sponsors
Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809 | Day 1 to Approximately Day 47 | PK: Cmax of LY4064809 |
| Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time T (AUC 0-tlast) | Day 1 to Approximately Day 47 | PK: AUC 0-tlast, where t is the last time point with a measurable concentration |
| Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Zero to Infinity (AUCinf) | Day 1 to Approximately Day 47 | PK: AUCinf |
Countries
United States
Outcome results
None listed