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

NCT ID: NCT06627088

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-23
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part A LY4100511 (tablet formulation) and [14C]-LY4100511 capsule

Participants will receive a single oral dose 1 or dose 2 unlabeled LY4100511 (tablet formulation) administered with a dose 1 \[14C\]-LY4100511 capsule containing approximately 100 µCi (3.7 MBq) of radioactivity in the fasted state

Group Type: EXPERIMENTAL

LY4100511 (DC-853)

Intervention Type: DRUG

Administered oral dose

[14C]-LY4100511 (DC-853) Administered oral dose

Intervention Type: DRUG

Administered oral dose

Part B LY4100511 (tablet formulation) and [14C]-LY4100511

Participants will receive a single oral dose 1 or dose 2 unlabeled LY4100511 (tablet formulation) in the fasted state, followed by a single intravenous (IV) dose of of \[14C\]-LY4100511, containing ≤1 μCi (≤37 kBq) of radioactivity, administered as an infusion.

Group Type: EXPERIMENTAL

LY4100511 (DC-853)

Intervention Type: DRUG

Administered oral dose

[14C]-LY4100511 (DC-853)

Intervention Type: DRUG

Administered IV infusion

Interventions

LY4100511 (DC-853)

Administered oral dose

Intervention Type: DRUG

[14C]-LY4100511 (DC-853) Administered oral dose

Administered oral dose

Intervention Type: DRUG

LY4100511 (DC-853)

Administered oral dose

Intervention Type: DRUG

[14C]-LY4100511 (DC-853)

Administered IV infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index between 18.0 and 32.0 kilogram per square meter (kg/m2), inclusive, and a body weight of ≥50 kilogram (kg)
• In good health and determined by no clinically significant finding from medical history, 12-lead ECG and vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia, e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin is not acceptable) at screening and check-in, and from the physical examination at check-in, as assessed by the Investigator or designee
• History of a minimum of 1 bowel movement per day.
• Able to provide a fecal sample between check-in on Day-2 and oral dosing on Day 1.

Exclusion Criteria

• Have a 12-lead ECG abnormality that, in the opinion of the Investigator

• increases the risks associated with participating in the study
• may confound ECG data analysis
• a QTcF & > 450 msec
• short PR interval & <120 msec or PR interval >220 msec
• second- or third-degree atrioventricular block
• intraventricular conduction delay with QRS 120 msec
• right bundle branch block
• left bundle branch block, or
• Wolff Parkinson-White syndrome.
• Have a current or recent acute, active infection (for example, for at least 30 days before screening and up to check-in, participants must have no symptoms or signs of infection in the absence of any anti-infective treatment).
• Had any malignancy within the past 5 years. Exceptions: successfully treated basal cell skin carcinoma or squamous cell skin carcinoma, with no evidence of recurrence or metastatic disease within the 3 years prior to baseline.
• Are immunocompromised.
• Have inflammatory bowel disease (IBD)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Fortrea Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

J5C-MC-FOAE

Identifier Type: OTHER

Identifier Source: secondary_id

27109

Identifier Type: -

Identifier Source: org_study_id