LY4064809 + Esomeprazole for Healthy Adults

Overseen By This is a single site clinical trial 1-877-CTLilly (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Disqualifiers: Metabolic, Biliary, GI, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy adults. It's not clear who can't join because the exclusion criteria are missing, but typically people with certain health conditions or taking conflicting medications would be excluded.

Inclusion Criteria

Participants must have a body mass index (BMI) within the range 18-32 kilogram/square meter (kg/m²) (inclusive)

I am not capable of becoming pregnant or I was assigned male at birth.

My blood pressure and pulse rate are within normal ranges.

Exclusion Criteria

I have or had a stomach or intestine disease.

I have not had major surgery in the last 30 days.

I have a history of blood disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive LY4064809 under different conditions: fasted, with a high-fat meal, and with esomeprazole

6 weeks

Multiple visits for blood tests and drug administration

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Esomeprazole

Trial Overview The study is testing LY4064809 to see how food and esomeprazole (a stomach acid reducer) affect its safety and how it's processed by the body. Participants will take the drug with and without food, and their blood will be tested.

How Is the Trial Designed?

Group I: Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect Experimental Treatment 1 Intervention

LY4064809 administered orally with esomeprazole

Group II: Group 2 Treatment A Fasted Experimental Treatment 1 Intervention

LY4064809 administered orally

Group III: Group 1 Treatment B High-Fat Meal Experimental Treatment 1 Intervention

LY4064809 administered orally

Group IV: Group 1 Treatment A Fasted Experimental Treatment 1 Intervention

LY4064809 administered orally

Who Is Running the Clinical Trial?

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

Lead Sponsor