New drug LY4515100 tested in healthy people for safety
NCT ID NCT07339722
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This early-phase trial is testing a new drug called LY4515100 in 40 healthy adults to see if it is safe and how the body handles it. Participants will receive either the drug or a placebo and stay overnight for monitoring. The study does not aim to treat any disease, but to gather important safety information for future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY4515100
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 123 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring. * Have a body mass index within the range of 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive). * Individuals not of childbearing potential (INOCBP) may participate in this trial. Exclusion Criteria: * Have donated 500 milliliters (mL) of blood within 30 days prior to dosing. * Have participated within the last 30 days in a clinical study involving an investigational medicinal product. If the previous investigational product (IP) has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed. * Participants with hemoglobin outside of the local laboratory normal reference range for age and sex, which is judged to be clinically significant by the investigator. * Participants with an estimated glomerular filtration rate \<90 mL/min/1.73 m². * Have a 12-lead Electrocardiogram (ECG) abnormality that, in the opinion of the investigator, * increases the risks associated with participating in the study * may confound ECG data analysis * Have used or intend to use over-the-counter or prescription medication including dietary or herbal medications within 7 days, or 14 days if the medication is a potential enzyme inducer, or 5 half-lives (whichever is longer), prior to dosing. * Smoke more than 10 cigarettes per day or the equivalent, including electronic cigarettes, and are unable to abide by investigative site smoking restrictions. * Have an average weekly alcohol intake that exceeds 14 units per week (males 65 years of age or younger) and 7 units per week (females and males greater than 65 years of age, if applicable) * Show evidence of * Human immunodeficiency virus (HIV) infection and/or positive human HIV antigen and/or antibodies * hepatitis C and/or positive hepatitis C antibody * hepatitis B and/or positive hepatitis B surface antigen. * Have liver disease. * Any clinical condition or procedure (for example, gastrointestinal obstruction, gastric bypass, or cholecystectomy) that may affect the absorption, distribution, or excretion of the study drug and confound pharmacokinetics (PK) assessment. * Part C Only: * Have history of neuropathy of any cause. * Have impaired hearing or a history of hearing problems. * Have any medical conditions, medical history, or are taking any medications that are contraindicated in the itraconazole prescribing information, such as prior history of hypersensitivity to itraconazole or other azoles. * Participants with any known history of thyroid disease
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fortrea Clinical Research Unit
RECRUITINGDallas, Texas, 75247, United States
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