A Study of LY4515100 in Healthy Participants

Lilly

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: LY4515100 via MAD; Drug: LY4515100 via SAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT07339722

J6V-MC-OIAB (Other Identifier)

27789

Details and patient eligibility

About

The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. 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 last up to 30 days and will include six overnight stays.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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/m^2) (inclusive).
• Individuals of childbearing potential (IOCBP) are excluded from this trial.
• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

LY4515100 of Part A (SAD)

Experimental group

Description:

Single-ascending doses of LY4515100 will be given orally

Treatment:

Drug: LY4515100 via SAD

LY4515100 of Part B (MAD)

Experimental group

Description:

Multiple-ascending doses of LY4515100 will be given orally

Treatment:

Drug: LY4515100 via MAD

Placebo Part A

Placebo Comparator group

Description:

Placebo will be given orally

Treatment:

Drug: LY4515100 via SAD

Placebo Part B

Placebo Comparator group

Description:

Placebo will be given orally

Treatment:

Drug: LY4515100 via MAD