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

Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY4064809

Study type: Interventional

Funder types: Industry

Identifiers

NCT06991179

J6M-MC-JSGC (Other Identifier)

27693

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Group 1 Treatment A Fasted

Experimental group

Description:

LY4064809 administered orally

Treatment:

Drug: LY4064809

Group 1 Treatment B High-Fat Meal

Experimental group

Description:

LY4064809 administered orally

Treatment:

Drug: LY4064809

Group 2 Treatment A Fasted

Experimental group

Description:

LY4064809 administered orally

Treatment:

Drug: LY4064809

Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect

Experimental group

Description:

LY4064809 administered orally with esomeprazole

Treatment:

Drug: LY4064809