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

NCT07519525 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27776J6M-MC-JSGF
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pharmacokinetics (PK): Plasma Maximum Concentration (Cmax) of LY4064809

  Baseline up to Day 14

• PK of Total Radioactivity: Plasma Area Under the Concentration Versus Time Curve (AUC) of [14C]-LY4064809

  Baseline up to Day 14

• Excretion and Recovery of Total Radioactivity in Urine

  Baseline up to Day 13

• Excretion and Recovery of Total Radioactivity and [14C] LY4064809 in Feces

  Baseline up to Day 13

Study Arms (1)

LY4064809

EXPERIMENTAL

Drug: LY4064809; Drug: [14C]-LY4064809

Interventions

LY4064809 DRUG

Administered orally

LY4064809

[14C]-LY4064809 DRUG

Administered by IV infusion

LY4064809

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704-2526, United States

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 9, 2026
• Study Start: March 27, 2026
• Primary Completion: May 26, 2026
• Study Completion: May 26, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)