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Clinical Trials in the USA / NCT07867327
Starting soon Phase 1

A Study of LY4515100 in Healthy Male Participants

NCT07867327 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2026-10
Last updated
2026-10-09

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

[¹⁴C]-LY4515100 Oral SolutionLY4515100 Tablet →[¹⁴C]-LY4515100 IV

[¹⁴C]-LY4515100 Oral Solution: \[¹⁴C\]-LY4515100 administered orally

LY4515100 Tablet: LY4515100 administered orally

[¹⁴C]-LY4515100 IV: \[¹⁴C\]-LY4515100 administered IV

Study summary

The main purpose of this study is to evaluate how the body handles \[¹⁴C\]-LY4515100. The study will investigate how much \[¹⁴C\]-LY4515100 enters the bloodstream from the stomach or intestines and is available to have an effect on the body, how the body changes \[¹⁴C\]-LY4515100 so that it can be used or removed, and how the body gets rid of \[¹⁴C\]-LY4515100. For each participant, the study will last about 9 weeks and will include a Clinical Research Unit (CRU) stay lasting between 10 and 30 days.

Eligibility

Sex
MALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation. * Have a body mass index (BMI) within the range of 18.0 to 35.0 kilograms per square meter (kg/m²), inclusive. Exclusion Criteria: * Have significant previous or current history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinal, 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 and hernia repair will be allowed. * Have a history of constipation or have had acute constipation within 3 weeks prior to check-in. * Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing, for example, serial x-ray or computed tomography scans, barium meal, or current employment in a job requiring radiation exposure monitoring.

Primary outcome measure(s)

  • Part 1: Urinary Excretion of [¹⁴C]-LY4515100 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered — Predose Up to Day 14
  • Part 1: Fecal Excretion of [¹⁴C]-LY4515100 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered — Predose Up to Day 14
  • Part 2: Dose Normalized Ratio of the Area Under the Concentration-Time Curve After Oral Administration (AUCpo) to Area Under the Concentration-Time Curve After Intravenous Administration (AUCiv) of LY4515100 — Predose Up to Day 14

Trial sites (1)

FacilityCityRegionStatus
Fortrea Clinical Research Unit Madison Wisconsin

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Other trials for the same condition

A Clinical Trial of Nemtabrutinib in Participants With Severe Kidney Disease (MK-1026-027) Recruiting
A Study of LY4515100 in Healthy Participants Recruiting
A Study of V132 in Healthy Older Participants (V132-001) Recruiting
A Study of LY4088044 in Healthy Participants Recruiting
A Study of Mirikizumab Solution (LY3074828) in Healthy Participants Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07867327 on ClinicalTrials.gov ↗ ← All trials in the USA