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

NCT ID: NCT06345794

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2024-06-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY4100511 (DC-853) + Itraconazole

Single oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally.

Group Type EXPERIMENTAL

LY4100511 (DC-853)

Intervention Type DRUG

Administered orally.

Itraconazole

Intervention Type DRUG

Administered orally.

LY4100511 (DC-853) + Fluconazole

Single oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally.

Group Type EXPERIMENTAL

LY4100511 (DC-853)

Intervention Type DRUG

Administered orally.

Fluconazole

Intervention Type DRUG

Administered orally.

LY4100511 (DC-853) + Carbamazepine

Single oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.

Group Type EXPERIMENTAL

LY4100511 (DC-853)

Intervention Type DRUG

Administered orally.

Carbamazepine

Intervention Type DRUG

Administered orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY4100511 (DC-853)

Administered orally.

Intervention Type DRUG

Itraconazole

Administered orally.

Intervention Type DRUG

Fluconazole

Administered orally.

Intervention Type DRUG

Carbamazepine

Administered orally.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DC-853

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

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

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Contact Lilly at 1-800-LillyRx (1-800-545-5979)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ICON San Antonio Clinical Research Unit

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

J5C-MC-FOAG

Identifier Type: OTHER

Identifier Source: secondary_id

DCE853103

Identifier Type: OTHER

Identifier Source: secondary_id

DCE853103

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dexamethasone in Cryptococcal Meningitis
NCT00000776 COMPLETED PHASE2