Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 65

LY4515100 in healthy adults

Official title: A Phase 1, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, and Pharmacokinetics of LY4515100 in Healthy Participants and an Open-Label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics, Safety, and Tolerability of LY4515100 and of LY4515100 on the Pharmacokinetics of CYP and Transporter Substrates in Healthy Participants

Run by Eli Lilly and Company · NCT07339722 · Data updated 2026-11-12

This study will test whether taking LY4515100 by mouth is safe and well tolerated in healthy adults and will measure how the body processes the drug.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment209 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations2 sites (Dallas, Texas and 1 other locations)
StatusRecruiting
StartedJanuary 15, 2026
Main results expectedMarch 2027
Study endsMarch 2027
Registry record updatedNovember 5, 2026
Trial IDNCT07339722 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal participants are healthy adults who are not of childbearing potential, have a BMI between 18.5 and 32 kg/m2, pass screening labs and cardiac checks, and can attend the Fortrea unit in Dallas for six overnight stays within a 30-day period.

Probably not a fit

People with active medical conditions, those who are of childbearing potential or pregnant, recent blood donors, or those with abnormal screening labs are unlikely to receive any health benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 trial uses single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts to characterize safety, tolerability, and pharmacokinetics of oral LY4515100 in healthy adults. Participants will be dosed and monitored at a clinical research unit with blood tests, vital signs, and cardiac monitoring to track how the drug is absorbed, distributed, metabolized, and eliminated. The trial lasts up to 30 days and includes six overnight stays for intensive monitoring. Individuals of childbearing potential are excluded and enrollment requires a BMI of 18.5–32 kg/m2 and normal screening labs.

Why it matters

Potential benefit: If results are favorable, the trial could define safe dose ranges and enable later studies that test whether LY4515100 helps people with the target condition.

How similar studies have gone: Single- and multiple-ascending-dose phase 1 designs are a standard step that has supported development of many drugs, but LY4515100 itself has not yet been shown to be effective in patients.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 (BMI) 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.
* Participants in the Combined Oral Contraceptive Arm of Part C only:

  * must be 18 to 45 years of age (inclusive).
  * have a BMI within the range of 18.5 to 30 kg/m².
  * may be healthy pre-menopausal assigned female at birth (AFAB) individuals of child bearing potential (IOCBP).

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 less than (\<) 90 milliliter per minute per 1.73 square meters (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
* Participants in the Combined Oral Contraceptive Arm of Part C only:

  * Are current smokers or have used nicotine, including tobacco or nicotine replacement products within 14 days prior to the first dose of combined oral contraceptive (COC), or plan to use nicotine, including tobacco or nicotine replacement products during the study.
  * Are at high risk for arterial or venous thrombotic diseases, autoimmune disease with lupus anticoagulants or anti-phospholipid syndrome, major surgery within the past 3 months, anticipated prolonged immobility.
  * Have abnormalities indicative of increased risk of VTE on the thrombophilia panel at screening.
  * Have undiagnosed abnormal uterine bleeding.
  * Have any history of breast, uterine or ovarian cancer.
  * Use of Vitamin C (greater than or equal to (≥) 500 mg/day) or acetaminophen within 14 days before dosing.
  * Have contraindications for the use of levonorgestrel/ethinyl estradiol.

Where it's running

  • Fortrea Clinical Research Unit
    Dallas, Texas, United States
    Recruiting
  • Fortrea Clinical Research Unit
    Madison, Wisconsin, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.