A Study of LY4515100 in Healthy Male Participants

NCT07867327 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27791J6V-MC-OIAC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• Part 1: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity

  Predose Up to Day 14

• Part 1: PK: Maximum Concentration (Cmax) of Total Plasma Radioactivity

  Predose Up to Day 14

• Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air

  Predose Up to Day 14

• Part 1: Total Number of Metabolites of LY4515100 in Urine, Feces, and Plasma

  Predose Up to Day 14

• Part 2: PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of [¹⁴C]-LY4515100

  Predose Up to Day 9

Study Arms (2)

[¹⁴C]-LY4515100 Part 1

EXPERIMENTAL

\[¹⁴C\]-LY4515100 containing radioactivity administered orally

Drug: [¹⁴C]-LY4515100 Oral Solution

LY4515100 + [¹⁴C]-LY4515100 Part 2

EXPERIMENTAL

LY4515100 administered orally with \[¹⁴C\]-LY4515100 containing radioactivity administered intravenously (IV)

Drug: LY4515100 Tablet; Drug: [¹⁴C]-LY4515100 IV

Interventions

[¹⁴C]-LY4515100 Oral Solution DRUG

\[¹⁴C\]-LY4515100 administered orally

[¹⁴C]-LY4515100 Part 1

LY4515100 Tablet DRUG

LY4515100 administered orally

LY4515100 + [¹⁴C]-LY4515100 Part 2

[¹⁴C]-LY4515100 IV DRUG

\[¹⁴C\]-LY4515100 administered IV

LY4515100 + [¹⁴C]-LY4515100 Part 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Individuals assigned male at birth (AMAB).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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: October 5, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)