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LY4100511 Interaction Study in Healthy Adults

Phase 1
Recruiting
Research Sponsored by DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 26 days
Awards & highlights

Summary

This trial aims to see how multiple doses of certain medications (itraconazole, fluconazole, and carbamazepine) affect the levels of LY4100511 in the body of healthy

Who is the study for?
This trial is for healthy adults who can participate in a study to understand how LY4100511 (DC-853) behaves in the body when taken with other drugs. Specific eligibility details are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.
What is being tested?
The trial is testing how LY4100511 (DC-853) interacts with itraconazole, fluconazole, and carbamazepine when given to healthy people. It's looking at what happens to LY4100511 levels in the blood after multiple doses of these other drugs.
What are the potential side effects?
While specific side effects aren't listed, generally studies like this monitor for any adverse reactions such as allergic responses, gastrointestinal symptoms, changes in mood or energy levels, headaches or dizziness that may occur from the drug combinations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 26 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 26 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853)
PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)

Trial Design

3Treatment groups
Experimental Treatment
Group I: LY4100511 (DC-853) + ItraconazoleExperimental Treatment2 Interventions
Single oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally.
Group II: LY4100511 (DC-853) + FluconazoleExperimental Treatment2 Interventions
Single oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally.
Group III: LY4100511 (DC-853) + CarbamazepineExperimental Treatment2 Interventions
Single oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole
2017
Completed Phase 2
~780
Fluconazole
2017
Completed Phase 4
~4820
Carbamazepine
2016
Completed Phase 4
~2690

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,629 Previous Clinical Trials
3,218,060 Total Patients Enrolled
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyLead Sponsor
5 Previous Clinical Trials
357 Total Patients Enrolled
Contact Lilly at 1-800-LillyRx (1-800-545-5979)Study DirectorEli Lilly and Company
6 Previous Clinical Trials
45 Total Patients Enrolled
~33 spots leftby Sep 2025
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