A Study of [14C]-LY4065967 in Healthy Participants

Launched by ELI LILLY AND COMPANY · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a drug called LY4065967 is absorbed, processed, and eliminated by the body in healthy men. The goal is to understand how the body handles this medication, which can help guide future research and development. The study has two parts and will last about two months for each participant.

Men who are generally healthy, aged between about 18 and 75, might be eligible to join. To qualify, participants must have a normal health check-up, including tests like blood work and heart monitoring, and should have regular bowel movements and a body weight within a typical range. The study will not include anyone with serious health conditions, recent surgeries affecting digestion, or certain allergies. During the study, participants will have blood samples taken to track how the drug moves through their body. It’s important to know that the study is not yet open for enrollment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead electrocardiograms (ECGs).
• • Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
• • Have venous access sufficient to allow for blood sampling.
• • Currently have a minimum of 1 bowel movement per day.
• • Have a body mass index within 18.0 to 35.0 kg/m², inclusive
• • Assigned male at birth
• • Exclusion Criteria
• • Have significant previous or current history of cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematological, neurological, thromboembolism, or bleeding disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study intervention; or of interfering with the interpretation of data.
• • Have a significant history of or current psychiatric disorders.
• • Have history of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs. Uncomplicated appendectomy, uncomplicated cholecystectomy, and hernia repair will be allowed.
• • Have a history of significant chronic constipation or have had acute constipation within 3 weeks prior to check-in.
• • Have any abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG analysis.
• • Have an abnormal blood pressure or pulse rate as determined by the investigator.
• • Have known allergies to LY4065967, related compounds, or any components of the formulation, or history of significant atopy.
• • Are currently enrolled in or have participated within the last 3 months in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. If the previous investigational product has a long t1/2, 5 half-lives or 30 days, whichever is longer, should have passed prior to check-in.
• • Have previously completed or withdrawn from this study or any other study investigating LY4065967 and have previously received LY4065967.
• • Part 2 only: Total \[14C\]-radioactivity measured in plasma exceeding 2.5 × the standard biological carbon ratio, 50 pMC when analyzed with carbon carrier radiodilution or 250 pMC when analyzed without carbon carrier dilution.