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OpenTrials
Completed

NCT Number: NCT07519525

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704-2526, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY4064809

Drug

Administered orally

[14C]-LY4064809

Drug

Administered by IV infusion

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.

    Time frame: Baseline up to Day 14

Secondary outcomes

  1. Pharmacokinetics (PK): Plasma Maximum Concentration (Cmax) of LY4064809

    Time frame: Baseline up to Day 14

    PK: Plasma Cmax of LY4064809

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

    Time frame: Baseline up to Day 14

    PK of Total Radioactivity: Plasma AUC

  3. Excretion and Recovery of Total Radioactivity in Urine

    Time frame: Baseline up to Day 13

    Investigate the rate and routes of excretion, including the mass balance in urine after dosing.

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

    Time frame: Baseline up to Day 13

    Investigate the rate and routes of excretion, including the mass balance in feces

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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