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HealthyPhase 1NCT07039045

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

A Phase 1 study testing LY4065967, [14C]-LY4065967 Oral and [14C]-LY4065967 IV in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY4065967, [14C]-LY4065967 Oral and [14C]-LY4065967 IV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
23 Jun 2025to 16 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fortrea Clinical Research Unit

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1, Open-label, 2-part Study of the Absorption, Metabolism, Excretion, and Bioavailability of [14C]-LY4065967 in Healthy Male Participants

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.

Conditions
Healthy
Being tested
LY4065967, [14C]-LY4065967 Oral, [14C]-LY4065967 IV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY4065967Drug

    Oral dose

  • [14C]-LY4065967 OralRadiation

    Oral dose

  • [14C]-LY4065967 IVRadiation

    IV dose

Study groups in NCT07039045
Study groupRoleWhat they receive
[14C]-LY4065967 Part 1ExperimentalA single dose containing [14C]-LY4065967.
Receives: Radiation: [14C]-LY4065967 Oral
LY4065967 Part 2ExperimentalA single dose of LY4065967 followed by a single dose of [14C]-LY4065967.
Receives: Drug: LY4065967; Radiation: [14C]-LY4065967 IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Percentage of Total Radioactive Dose in Urine and Fecal Excretion

    Measured: Baseline through Study Completion (21 days)

  2. Part 2: Plasma Area Under the Concentration-time Curve from Zero to Infinity (AUC(0-ꝏ)) for LY4065967

    Measured: Baseline through Study Completion (9 Days)

Secondary outcomes (7)

  1. Part 1 Pharmacokinetic (PK): Plasma AUC(0-ꝏ) for Total Radioactivity and LY4065967

    Measured: Baseline through Study Completion (21 days)

  2. Part 1 PK: Plasma Maximum Concentration (Cmax) for Total Radioactivity and LY4065967

    Measured: Baseline through Study Completion (21 days)

  3. Part 1 PK: Blood Total Radioactivity AUC

    Measured: Baseline through Study Completion (21 days)

  4. Part 1 PK: Blood Total Radioactivity Cmax

    Measured: Baseline through Study Completion (21 days)

  5. Part 1: Total Number and Identification of Metabolites

    Measured: Baseline through Study Completion (21 days)

  6. Part 2 PK: Plasma AUC(0-ꝏ) for Total Radioactivity, [14C]-LY4065967, and LY4065967

    Measured: Baseline through Study Completion (9 Days)

  7. Part 2 PK: Plasma Cmax for Total Radioactivity, [14C]-LY4065967, and LY4065967

    Measured: Baseline through Study Completion (9 Days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start23 Jun 2025
  3. Primary completion16 Aug 2025
  4. Study completion16 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07039045
Sponsor's protocol ID
27203
Other IDs
J4X-MC-LWCB
Status last verified
Sep 2025
First submitted
19 Jun 2025
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY4065967, [14C]-LY4065967 Oral and [14C]-LY4065967 IV in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Percentage of Total Radioactive Dose in Urine and Fecal Excretion (time frame: Baseline through Study Completion (21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07039045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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