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Completed

NCT Number: NCT06627088

A Study of LY4100511 (DC-853) Mass Balance and Absolute Bioavailability of 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY4100511 (DC-853)

Drug

Administered oral dose

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

Drug

Administered oral dose

[14C]-LY4100511 (DC-853)

Drug

Administered IV infusion

Primary outcomes

  1. 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)

  2. Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for [14C] LY4100511

    Time frame: Up until Day 15

  3. Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for LY4100511

    Time frame: Up until Day 15

  4. Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for TRA

    Time frame: Up until Day 15

  5. Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for [14C] LY4100511

    Time frame: Up until Day 15

  6. Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for LY4100511

    Time frame: Up until Day 15

  7. Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for TRA

    Time frame: Up until Day 15

  8. Part A: PK Maximum Observed Plasma Concentration (Cmax) for [14C] LY4100511

    Time frame: Up until Day 15

  9. Part A: PK Maximum Observed Plasma Concentration (Cmax) for LY4100511

    Time frame: Up until Day 15

  10. Part A: PK Maximum Observed Plasma Concentration (Cmax) for TRA

    Time frame: Up until Day 15

  11. Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for [14C] LY4100511

    Time frame: Up until Day 15

  12. Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for LY4100511

    Time frame: Up until Day 15

  13. Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for TRA

    Time frame: Up until Day 15

  14. Part A: PK Terminal Elimination Half Life (t1/2) for [14C] LY4100511

    Time frame: Up until Day 15

  15. Part A: PK Terminal Elimination Half Life (t1/2) for LY4100511

    Time frame: Up until Day 15

  16. Part A: PK Terminal Elimination Half Life (t1/2) for TRA

    Time frame: Up until Day 15

  17. Part A: Urinary Recovery and Excretion of TRA (Aet1-t2)

    Time frame: Up until Day 15

  18. Part A: Urinary Recovery and Excretion of [14C] LY4100511 (Aet1-t2)

    Time frame: Up until Day 15

  19. Part A: Renal clearance of [14C] LY4100511 (CLR)

    Time frame: Up until Day 15

  20. Part B: Pharmacokinetic (PK): absolute bioavailability (Fabs) of LY4100511

    Time frame: Up until Day 6

  21. Part B: Recovery of TRA in urine and feces

    Time frame: Up until Day 6

  22. Part B: Recovery of [14C]-LY4100511 in feces (Aet1-t2) following IV dosing

    Time frame: Up until Day 6

  23. Part B: Recovery of [14C]-LY4100511 in urine (Aet1-t2) following IV dosing

    Time frame: Up until Day 6

  24. 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

  25. Part B: PK Maximum Observed Plasma Concentration (Cmax) of LY4100511following IV dosing

    Time frame: Up until Day 6

  26. Part B: PK Time to Maximum Observed Plasma Concentration (tmax) of LY4100511following IV dosing

    Time frame: Up until Day 6

  27. Part B: PK Terminal Elimination Half Life (t1/2) following IV dosing

    Time frame: Up until Day 6

  28. Part B: PK Clearance (CL) following IV dosing

    Time frame: Up until Day 6

  29. Part B: PK renal clearance (CLr) following IV dosing [Time Frame: Up until Day 6]

    Time frame: Up until Day 6

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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