NCT06627088

A Study of LY4100511 (DC-853) Mass Balance and Absolute Bioavailability of LY4100511 in Healthy Male Participants

A Phase 1, Open-label, Two-part Study of the Absorption, Metabolism, Excretion, and Bioavailability of LY4100511 (DC-853) Following Administration of [14C]-LY4100511 in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study has two parts, Part A and Part B. The purpose of Part A is to determine the absorption, metabolism, and excretion (AME) of \[14C\]-LY4100511 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants after a single oral dose of LY4100511. The purpose of Part B is to determine the absolute bioavailability of LY4100511 in humans, to further analyze the rate and routes of excretion, including the mass balance, and to further investigate the pharmacokinetics (PK) of \[14C\]-LY4100511, LY4100511, and TRA.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LY4100511 (DC-853)	Administered oral dose
DRUG	[14C]-LY4100511 (DC-853) Administered oral dose	Administered oral dose
DRUG	LY4100511 (DC-853)	Administered oral dose
DRUG	[14C]-LY4100511 (DC-853)	Administered IV infusion

Timeline

• Start date: 2024-08-23
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-10-04
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study