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

NCT07039045 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27203J4X-MC-LWCB
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  Baseline through Study Completion (21 days)

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

  Baseline through Study Completion (9 Days)

Secondary Outcomes (7)

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

  Baseline through Study Completion (21 days)

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

  Baseline through Study Completion (21 days)

• Part 1 PK: Blood Total Radioactivity AUC

  Baseline through Study Completion (21 days)

• Part 1 PK: Blood Total Radioactivity Cmax

  Baseline through Study Completion (21 days)

• Part 1: Total Number and Identification of Metabolites

  Baseline through Study Completion (21 days)

Study Arms (2)

[14C]-LY4065967 Part 1

EXPERIMENTAL

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

Radiation: [14C]-LY4065967 Oral

LY4065967 Part 2

EXPERIMENTAL

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

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

Interventions

LY4065967 DRUG

Oral dose

LY4065967 Part 2

[14C]-LY4065967 Oral RADIATION

Oral dose

[14C]-LY4065967 Part 1

[14C]-LY4065967 IV RADIATION

IV dose

LY4065967 Part 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 26, 2025
• Study Start: June 23, 2025
• Primary Completion: August 16, 2025
• Study Completion: August 16, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)