Recruiting
Phase 1

LY4515100

Sponsor:

Eli Lilly and Company

Code:

NCT07339722

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

LY4515100 via SAD

LY4515100 via MAD

LY4515100

Itraconazole

Caffeine

Study Details

Brief summary:

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.

Conditions

Healthy

Study ID

NCT07339722

Start date

Jan 15, 2026

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

123 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY4515100 of Part A (SAD)

Single-ascending doses of LY4515100 will be given orally

experimental: LY4515100 of Part B (MAD)

Multiple-ascending doses of LY4515100 will be given orally

experimental: LY4515100 and Itraconazole of Part C

LY4515100 and Itraconazole will be given orally

experimental: LY4515100 and Metformin of Part C

LY4515100 and Metformin will be given orally

experimental: LY4515100 and Transporter Substrates or Renal Marker of Part C

LY4515100 and Transporter Substrates or Renal Marker will be given either orally or intravenously (IV)

placebo comparator: Placebo Part A

Placebo will be given orally

placebo comparator: Placebo Part B

Placebo will be given orally

Interventions

LY4515100 via SAD

given orally

LY4515100 via MAD

given orally

LY4515100

given orally

Itraconazole

given orally

Caffeine

given orally

Digoxin

given orally

Iohexol

given IV

Metformin

given orally

Rosuvastatin

given orally

Placebo

given orally

Primary outcome measure

  • Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100 in Parts A and B [ Time Frame: Day 1 up to Day 30 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Fortrea Clinical Research Unit

Recruiting

Dallas, Texas, United States, 75247

Contacts

866-429-3700

Principal Investigator:

Gene Voskuhl

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-07-29.