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HealthyPhase 1NCT06627088

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

A Phase 1 study testing LY4100511 (DC-853), [14C]-LY4100511 (DC-853) Administered oral dose and [14C]-LY4100511 (DC-853) in people with Healthy, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY4100511 (DC-853), [14C]-LY4100511 (DC-853) Administered oral dose and [14C]-LY4100511 (DC-853)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
23 Aug 2024to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fortrea Clinical Research Unit

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official 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

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
Being tested
LY4100511 (DC-853), [14C]-LY4100511 (DC-853) Administered oral dose, [14C]-LY4100511 (DC-853)
Keywords
LY4100511, DC-853

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY4100511 (DC-853)Drug

    Administered oral dose

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

    Administered oral dose

  • LY4100511 (DC-853)Drug

    Administered oral dose

  • [14C]-LY4100511 (DC-853)Drug

    Administered IV infusion

Study groups in NCT06627088
Study groupRoleWhat they receive
Part A LY4100511 (tablet formulation) and [14C]-LY4100511 capsuleExperimentalParticipants 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
Receives: Drug: LY4100511 (DC-853); Drug: [14C]-LY4100511 (DC-853) Administered oral dose
Part B LY4100511 (tablet formulation) and [14C]-LY4100511ExperimentalParticipants 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.
Receives: Drug: LY4100511 (DC-853); Drug: [14C]-LY4100511 (DC-853)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Total Radioactivity Recovery and Excretion (TRA)

    Total radioactivity recovery and excretion (fet1-t2 and Aet1-t2) in urine and feces (and vomitus, if available)

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 15

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

    Measured: Up until Day 6

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

    Measured: Up until Day 6

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

    Measured: Up until Day 6

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

    Measured: Up until Day 6

  24. Part B: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) of LY4100511 following IV dosing

    Measured: Up until Day 6

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

    Measured: Up until Day 6

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

    Measured: Up until Day 6

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

    Measured: Up until Day 6

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

    Measured: Up until Day 6

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

    Measured: Up until Day 6

Secondary outcomes (1)

  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

    A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events Module.

    Measured: Up until Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start23 Aug 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06627088
Sponsor's protocol ID
27109
Other IDs
J5C-MC-FOAE
Status last verified
Jan 2025
First submitted
12 Sep 2024
Last updated
24 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY4100511 (DC-853), [14C]-LY4100511 (DC-853) Administered oral dose and [14C]-LY4100511 (DC-853) in people with Healthy, run by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Total Radioactivity Recovery and Excretion (TRA) (time frame: Up until Day 15). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06627088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.

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