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Completed

NCT Number: NCT06991179

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron Clinical Pharmacology Center Inc

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4064809

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809

    Time frame: Day 1 to Approximately Day 47

    PK: Cmax of LY4064809

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

    Time frame: Day 1 to Approximately Day 47

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

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

    Time frame: Day 1 to Approximately Day 47

    PK: AUCinf

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 1, Open-Label Study to Evaluate the Effects of Food and Multiple-Doses of Esomeprazole on the Pharmacokinetics of a Single Oral Dose of LY4064809 in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 26, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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