A Study of [14C]-LY4064809 in Healthy Participants

A Phase 1, Open-label Study of the Absolute Bioavailability of [14C]-LY4064809 in Healthy Adult Participants

The purpose of this study is to determine in healthy participants the percentage of LY4064809 that enters bloodstream after oral administration. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 21 days, not including screening. Participants will remain in the clinical research center for 14 days.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: LY4064809; Drug: [14C]-LY4064809

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2526
      • Fortrea Clinical Research Unit Inc. - Madison

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Must be healthy as shown by medical history, physical examination, laboratory tests and heart monitoring
• Must have normal blood pressure and pulse rate
• Must have a history of a minimum of 1 bowel movement per day
• Must have body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m2)
• Must be healthy men or healthy women who are not of childbearing potential
• Healthy men with partners who can become pregnant must remain abstinent or use contraceptives consistent with local regulations

Exclusion Criteria:

• Must not have a significant history or presence of metabolic disease, heart, liver, gallbladder, bile ducts, digestive, blood or nervous system disorders that could affect the way the body absorbs and processes the study drug
• Must not have an abnormal electrocardiogram (ECG)
• Must not have a history of major surgery within 30 days of entering study
• Must not have a history of cancer within 5 years of screening
• Must not have known allergies to LY4064809 or related compounds
• Must not have history of multiple or severe drug reactions or allergies which required treatment with steroids or epinephrine
• Must not have history or presence of psychiatric conditions that would prevent the participant from following study instructions.
• Must not use medications, except acetaminophen within 14 days of the first dose of LY4064809 and during the clinic stay
• Must not have participated in and been dosed in more than 2 radiolabeled drug studies in the last 12 months
• Must not have had exposure to significant diagnostic, therapeutic or employment-related radiation within 12 months
• Must not have participated in any other radiolabeled investigational study drug trial within 6 months prior to admission.
• Must not show evidence of human immunodeficiency Virus (HIV) infection or positive HIV-1 and HIV-2 antibodies
• Must not have evidence of Hepatitis C virus (HCV) infection or a positive HCV antibody test.
• Must not have evidence of Hepatitis B virus (HBV) infection or a positive Hepatitis B surface antigen (HBsAg)
• Must not have alcohol intake deemed significant by the investigator
• Must not use tobacco, smoking-cessation products, e-cigarettes (nicotine and non-nicotine), or nicotine products within 90 days prior to LY4064809 administration and discharge from the clinical research unit (CRU) or early termination (ET)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4064809	Drug: LY4064809; Administered orally; Drug: [14C]-LY4064809; Administered by IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the absolute bioavailability (F) of LY4064809 following administration of a single oral dose compared to an intravenous reference dose in healthy participants.	Baseline up to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Plasma Maximum Concentration (Cmax) of LY4064809	PK: Plasma Cmax of LY4064809	Baseline up to Day 14
PK of Total Radioactivity: Plasma Area Under the Concentration Versus Time Curve (AUC) of [14C]-LY4064809	PK of Total Radioactivity: Plasma AUC	Baseline up to Day 14
Excretion and Recovery of Total Radioactivity in Urine	Investigate the rate and routes of excretion, including the mass balance in urine after dosing.	Baseline up to Day 13
Excretion and Recovery of Total Radioactivity and [14C] LY4064809 in Feces	Investigate the rate and routes of excretion, including the mass balance in feces	Baseline up to Day 13

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 27776; J6M-MC-JSGF (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