Study of LY4515100 in Healthy Participants
This study is testing a drug called LY4515100, given by mouth, to see how safe it is and how well healthy people can tolerate it. Researchers will also take blood samples to understand how your body handles the drug and what effects it has. The study is looking for 40 healthy volunteers between 18 and 65 years old. To join, you must be in good health, have a body mass index (BMI) between 18.5 and 32.0, and not be able to become pregnant. The main goal is to track any serious side effects from LY4515100 for up to 30 days. The current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 healthy participants.
- What's involved
- The study will last up to 30 days and includes six overnight stays. You will have medical evaluations, physical exams, laboratory tests, vital sign checks, and heart monitoring.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for serious side effects from Day 1 up to Day 30.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07339722
A Study of LY4515100 in Healthy Participants
Recruiting
PHASE1Ages 18–65InterventionalBasic scienceEli Lilly and Company
~123 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:LY4515100 via SADLY4515100 via MADLY4515100ItraconazoleCaffeineDigoxin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100 in Parts A and B
Measured over Day 1 up to Day 30
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Who to contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100 in Parts A and BDay 1 up to Day 30
SAEs of LY4515100