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

NCT06991179 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27693J6M-MC-JSGC
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809

  PK: Cmax of LY4064809

  Day 1 to Approximately Day 47

• Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time T (AUC 0-tlast)

  PK: AUC 0-tlast, where t is the last time point with a measurable concentration

  Day 1 to Approximately Day 47

• Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Zero to Infinity (AUCinf)

  PK: AUCinf

  Day 1 to Approximately Day 47

Study Arms (4)

Group 1 Treatment A Fasted

EXPERIMENTAL

LY4064809 administered orally

Drug: LY4064809

Group 1 Treatment B High-Fat Meal

EXPERIMENTAL

LY4064809 administered orally

Drug: LY4064809

Group 2 Treatment A Fasted

EXPERIMENTAL

LY4064809 administered orally

Drug: LY4064809

Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect

EXPERIMENTAL

LY4064809 administered orally with esomeprazole

Drug: LY4064809

Interventions

LY4064809 DRUG

Administered orally

Group 1 Treatment A Fasted; Group 1 Treatment B High-Fat Meal; Group 2 Treatment A Fasted; Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Pharmaron Clinical Pharmacology Center Inc

Baltimore, Maryland, 21201, United States

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 26, 2025
• Study Start: May 20, 2025
• Primary Completion: September 2, 2025
• Study Completion: September 2, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)