Healthy volunteers help test how food and acid pills change drug absorption
NCT ID NCT06991179
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage study in 36 healthy adults tests how food and a common stomach-acid drug (esomeprazole) affect the body's processing of an experimental drug called LY4064809. Participants take a single dose of LY4064809 under different conditions, and blood samples measure drug levels. The goal is to gather safety and absorption data, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY4064809
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
36 people
The number who actually took part.
- Started
-
May 2025
- Finished
-
Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Pharmaron Clinical Pharmacology Center Inc
Baltimore, Maryland, 21201, United States
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