COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2025-05-20

Study Completion:2025-09-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06991179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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 * 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

Inclusion Criteria

Exclusion 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

* 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
* 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

Contacts and Locations

Principal Investigator

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)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Pharmaron Clinical Pharmacology Center Inc

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

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

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-20

Study Completion Date2025-09-02

Study Record Updates

Study Start Date2025-05-20

Study Completion Date2025-09-02

Terms related to this study

Additional Relevant MeSH Terms

Healthy