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HealthyPhase 1NCT06345794

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants

A Phase 1 study testing LY4100511 (DC-853), Itraconazole and Fluconazole 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 main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY4100511 (DC-853), Itraconazole and Fluconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
3 Apr 2024to 18 Jun 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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²)
  • Males who agree to follow contraceptive requirements and women of not childbearing potential
  • Have body weight greater than or equal to (>=) 50 Kilograms at screening.
  • Must have a negative Interferon-Gamma Release Assays (IGRA) testing at screening
  • Must have been stopped all the prescribed medication at least 14 days prior to admission to the clinical site
  • Ability and willingness to abstain from alcohol, caffeine, and methylxanthine-containing beverages or food 2 days prior to admission to the clinical site
  • Abstain from any strenuous physical exercise from 4 days prior to admission and during confinement at the clinical site

Who cannot join

  • Have a history of relevant drug and/or food allergies, or sensitivity to medications used in the current study
  • Females participants who are currently breastfeeding
  • Have History of alcohol abuse or drug addiction
  • Unable to abstain from tobacco products within the 2 days prior to admission and during confinement at the clinical site
  • Have Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies
  • Consumption of any nutrients known to modulate CYP450 enzymes activity
Show all 9Show fewer
  • Are immunocompromised
  • Have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette-Guérin within 28 days of screening or intend to receive them during the study
  • Have had any malignancy within the past 5 years

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ICON San Antonio Clinical Research Unit

    San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: A Phase 1, Single-Center, Open-Label, 3-Cohort, Fixed-Sequence, Drug-Drug Interaction Study To Assess The Pharmacokinetics Of LY4100511 (DC-853) When Orally Administered Alone, When Coadministered With Itraconazole, Fluconazole, Or Carbamazepine In Healthy Adult Participants

The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine.

Conditions
Healthy
Being tested
LY4100511 (DC-853), Itraconazole, Fluconazole, Carbamazepine
Keywords
DC-853, LY4100511

What participants receive

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

  • LY4100511 (DC-853)Drug

    Also called DC-853

    Administered orally.

  • ItraconazoleDrug

    Administered orally.

  • FluconazoleDrug

    Administered orally.

  • CarbamazepineDrug

    Administered orally.

Study groups in NCT06345794
Study groupRoleWhat they receive
LY4100511 (DC-853) + ItraconazoleExperimentalSingle oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally.
Receives: Drug: LY4100511 (DC-853); Drug: Itraconazole
LY4100511 (DC-853) + FluconazoleExperimentalSingle oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally.
Receives: Drug: LY4100511 (DC-853); Drug: Fluconazole
LY4100511 (DC-853) + CarbamazepineExperimentalSingle oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.
Receives: Drug: LY4100511 (DC-853); Drug: Carbamazepine

What is being measured

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

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)

    Measured: Predose up to 26 Days

  2. PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853)

    Measured: Predose up to 26 Days

  3. PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853)

    Measured: Predose up to 26 Days

Timeline

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

  1. First posted3 Apr 2024
  2. Study start3 Apr 2024
  3. Primary completion18 Jun 2024
  4. Study completion18 Jun 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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06345794
Sponsor's protocol ID
DCE853103
Other IDs
J5C-MC-FOAG, DCE853103
Status last verified
Apr 2025
First submitted
28 Mar 2024
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
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), Itraconazole and Fluconazole 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 7 inclusion and 9 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 27 Apr 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?

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853) (time frame: Predose up to 26 Days). The study lists 3 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 NCT06345794.

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 27 Apr 2025.

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