A Study of LY3866288 in Healthy Participants

A Phase 1, Open-label, Randomized, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of LY3866288 in Healthy Participants

The purpose of this study is to evaluate how well LY3866288 is tolerated and what side effects may occur in healthy participants. The study drug will be administered orally. Blood tests will be performed to check how much LY3866288 gets into the bloodstream and how long it takes the body to eliminate it.

The study will last up to approximately 9 weeks including screening.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3866288

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Females must be of nonchildbearing potential or of childbearing potential and agree to use contraception
• Males must either be infertile via bilateral orchiectomy or vasectomized at least 90 days prior to screening with proper documentation
• Body mass index (BMI) between 18.5 and 32.0 kilogram per square meter (kg/m²)
• In good general health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram (ECGs), vital signs measurements, or clinical laboratory evaluations at screening and/or check-in as assessed by the investigator (or designee)

Exclusion Criteria:

• Females only: Are lactating or pregnant

• Any history or presence of disease(s), deemed clinically significant:

  • Dermatological disease
  • Liver disease
  • Metabolic disease, including congenital nonhemolytic hyperbilirubinemia (e.g., Gilbert syndrome)
  • Gastrointestinal disease, including peptic ulcer disease, active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug, or gastric reduction surgery. Note: participants with a history of appendectomy and/or inguinal hernia repairs will be acceptable
  • Biliary disease, including cholecystectomy
  • Cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin)
  • History or current evidence of ophthalmic disorder, such as central serous retinopathy or retinal vein occlusion, active wet age-related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
  • Clinically significant, active cardiovascular disease or history of myocardial infarction within 6 months prior to first dose, or 12-lead ECG abnormalities that are clinically significant at screening
• History of alcohol and/or drug abuse within 2 years prior to screening
• Have been on a diet incompatible with the on-study diet, in the opinion of the investigator (or designee), and as confirmed by the sponsor, within the 30 days prior to Day 1 and throughout
• Use of tobacco, smoking cessation products, products containing nicotine, or e-cigarettes (nicotine and non-nicotine) within 90 days prior to screening and throughout

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3866288 Cohort 1 (High-Fat Meal); LY3866288 single and multiple capsules administered orally under fasted/fed conditions in cross-over manner within cohort	Drug: LY3866288; Administered orally
Experimental: LY3866288 Cohort 2 (Low-Fat Meal); LY3866288 single and multiple capsules administered orally under fasted/fed conditions in cross-over manner within cohort	Drug: LY3866288; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration of LY3866288	PK: AUC From Time 0 to the Time of the Last Quantifiable Concentration of LY3866288	Baseline to Study Completion (Up to 3 Weeks)
PK: AUC Extrapolated to Infinity of LY3866288	PK: AUC Extrapolated to Infinity of LY3866288	Baseline to Study Completion (Up to 3 Weeks)
PK: Maximum Concentration (Cmax) of LY3866288	PK: Cmax of LY3866288	Baseline to Study Completion (Up to 3 Weeks)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Actual): December 2, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 27311; J4G-OX-JZVC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No