Scientists track mystery Drug's journey through healthy men
NCT ID NCT07039045
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This completed Phase 1 study looked at how healthy male volunteers absorb, break down, and eliminate the experimental drug LY4065967. Sixteen participants received the drug by mouth and by IV, and researchers measured levels in blood, urine, and stool. The goal was purely to understand the drug's behavior in the body, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY4065967 (a drug being studied, given by mouth and by IV)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
16 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704, United States
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