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

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to investigate the absorption, metabolism, excretion, and bioavailability of LY4065967 in healthy male participants. This is a 2-part study. The study will last about 58 days for participants in Part 1 and about 60 days for participants in Part 2.

Key facts

Study ID

NCT07039045

Run by

Eli Lilly and Company

People needed

16

Starts

2025-06-23

Expected to finish

2025-08-16

Last updated by the study team

2025-09-09

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Fortrea Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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