CClinicalTrials.gg
CompletedNCT07039045Updated Sep 9, 2025

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

A Phase 1 interventional study of LY4065967 and [14C]-LY4065967 Oral in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Aug 2025, 1 year 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    [14C]-LY4065967 Part 1

    A single dose containing \[14C\]-LY4065967.

    Radiation: [14C]-LY4065967 Oral

  • Experimental
    LY4065967 Part 2

    A single dose of LY4065967 followed by a single dose of \[14C\]-LY4065967.

    Drug: LY4065967 · Radiation: [14C]-LY4065967 IV

Interventions

  • DrugLY4065967

    Oral dose

  • Radiation[14C]-LY4065967 Oral

    Oral dose

  • Radiation[14C]-LY4065967 IV

    IV dose

06

What researchers measure

Primary outcomes

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

    Time frame: 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

    Time frame: Baseline through Study Completion (9 Days)

Secondary outcomes

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

    Time frame: Baseline through Study Completion (21 days)

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

    Time frame: Baseline through Study Completion (21 days)

  3. Part 1 PK: Blood Total Radioactivity AUC

    Time frame: Baseline through Study Completion (21 days)

  4. Part 1 PK: Blood Total Radioactivity Cmax

    Time frame: Baseline through Study Completion (21 days)

  5. Part 1: Total Number and Identification of Metabolites

    Time frame: Baseline through Study Completion (21 days)

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

    Time frame: Baseline through Study Completion (9 Days)

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

    Time frame: Baseline through Study Completion (9 Days)

07

Study locations

1 site
  • Fortrea Clinical Research Unit
    Madison, Wisconsin 53704, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07039045
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jun 26, 2025
Start date
Jun 23, 2025
Primary completion
Aug 16, 2025
Completion
Aug 16, 2025
Last update
Sep 9, 2025

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion