How much oral LY4064809 reaches the bloodstream
A Phase 1, Open-label Study of the Absolute Bioavailability of [14C]-LY4064809 in Healthy Adult Participants
This study will test how much of the experimental drug LY4064809 gets into the bloodstream after a single oral dose in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT07519525 on ClinicalTrials.gov |
What this trial studies
Healthy adult volunteers will receive an oral dose of LY4064809 labeled with carbon-14 ([14C]) so researchers can track how much of the drug is absorbed into the blood. Blood samples and safety tests, including ECGs and laboratory panels, will be collected over about 14 days while participants stay in the clinical research unit, with the full participation lasting about 21 days including screening and follow-up. The primary goal is to quantify the percentage of the administered dose that enters systemic circulation and to characterize basic pharmacokinetics. The study is a Phase 1, single-dose pharmacokinetic and absorption study conducted in healthy, non-childbearing adults.
Who should consider this trial
Good fit: Ideal participants are healthy adults with BMI 18–32 kg/m2, normal vital signs and ECG, not of childbearing potential, who can remain at the Madison, Wisconsin clinical unit for about 14 days.
Not a fit: People with active medical conditions, abnormal ECGs, recent major surgery, recent cancer history, or who are pregnant or of childbearing potential are not eligible and are unlikely to receive any direct benefit.
Why it matters
Potential benefit: If successful, the results will help developers choose appropriate dosing and safety monitoring for future studies of LY4064809.
How similar studies have performed: Radiolabeled ADME studies in healthy volunteers are a standard method and have reliably measured absorption and basic pharmacokinetics for many investigational drugs.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Madison, Wisconsin
- Fortrea Clinical Research Unit Inc. - Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.