A Study of LY4515100 in Healthy Participants
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. LY4515100 will be given by itself or with other medicines. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will have 3 parts and will last about 50 days. For each participant in Part A, the study will include a stay in the Clinical Research Unit (CRU) lasting about 6 days. For each participant in Part B, the study will include a stay in the CRU lasting about 15 days. For each participant in Part C, the study will include up to 2 stays in the CRU each lasting between 7-28 days.
Key facts
- Study ID
- NCT07339722
- Run by
- Eli Lilly and Company
- People needed
- 123
- Starts
- 2026-01-15
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Fortrea Clinical Research Unit — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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