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

January 23, 2025 updated by: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There is a single site in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Fortrea Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: LY4100511 (DC-853)
Administered oral dose
Drug: [14C]-LY4100511 (DC-853) Administered oral dose
Administered oral dose
Experimental: 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.
Drug: LY4100511 (DC-853)
Administered oral dose
Drug: [14C]-LY4100511 (DC-853)
Administered IV infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A: Total Radioactivity Recovery and Excretion (TRA)
Time Frame: Up until Day 15
Total radioactivity recovery and excretion (fet1-t2 and Aet1-t2) in urine and feces (and vomitus, if available)
Up until Day 15
Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for [14C] LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for TRA
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for [14C] LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for TRA
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Maximum Observed Plasma Concentration (Cmax) for [14C] LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Maximum Observed Plasma Concentration (Cmax) for LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Maximum Observed Plasma Concentration (Cmax) for TRA
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for [14C] LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for TRA
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Terminal Elimination Half Life (t1/2) for [14C] LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Terminal Elimination Half Life (t1/2) for LY4100511
Time Frame: Up until Day 15
Up until Day 15
Part A: PK Terminal Elimination Half Life (t1/2) for TRA
Time Frame: Up until Day 15
Up until Day 15
Part A: Urinary Recovery and Excretion of TRA (Aet1-t2)
Time Frame: Up until Day 15
Up until Day 15
Part A: Urinary Recovery and Excretion of [14C] LY4100511 (Aet1-t2)
Time Frame: Up until Day 15
Up until Day 15
Part A: Renal clearance of [14C] LY4100511 (CLR)
Time Frame: Up until Day 15
Up until Day 15
Part B: Pharmacokinetic (PK): absolute bioavailability (Fabs) of LY4100511
Time Frame: Up until Day 6
Up until Day 6
Part B: Recovery of TRA in urine and feces
Time Frame: Up until Day 6
Up until Day 6
Part B: Recovery of [14C]-LY4100511 in feces (Aet1-t2) following IV dosing
Time Frame: Up until Day 6
Up until Day 6
Part B: Recovery of [14C]-LY4100511 in urine (Aet1-t2) following IV dosing
Time Frame: Up until Day 6
Up until Day 6
Part B: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) of LY4100511 following IV dosing
Time Frame: Up until Day 6
Up until Day 6
Part B: PK Maximum Observed Plasma Concentration (Cmax) of LY4100511following IV dosing
Time Frame: Up until Day 6
Up until Day 6
Part B: PK Time to Maximum Observed Plasma Concentration (tmax) of LY4100511following IV dosing
Time Frame: Up until Day 6
Up until Day 6
Part B: PK Terminal Elimination Half Life (t1/2) following IV dosing
Time Frame: Up until Day 6
Up until Day 6
Part B: PK Clearance (CL) following IV dosing
Time Frame: Up until Day 6
Up until Day 6
Part B: PK renal clearance (CLr) following IV dosing [Time Frame: Up until Day 6]
Time Frame: Up until Day 6
Up until Day 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with One or More Adverse Events (AEs), and Serious Adverse Events (SAEs) considered by the investigator to be related to study drug administration
Time Frame: Up until Day 8
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events Module.
Up until Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27109
  • J5C-MC-FOAE (Other Identifier: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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