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LY4100511 for Healthy Subjects

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
Females must be of childbearing potential
Have body mass index (BMI) between 18.0 and 32.0 kg/m², and a body weight of greater than or equal to 50 kg
Must not have
Show evidence of active or latent tuberculosis (TB)
Have a 12-lead ECG abnormality that increases the risks associated with participating in the study, may confound ECG data analysis, or meets specific criteria such as QTCF >450 msec for males, or >470 msec for females, short PR interval <120 msec or PR interval >220 msec, second or third degree atrioventricular block, intraventricular conduction delay with QRS >120 msec, complete right bundle branch block, left bundle branch block, or Wolff Parkinson-White syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and how well the drug LY4100511 (also known as DC-853) is tolerated in healthy individuals. They will also study how the drug behaves in the

Who is the study for?
This trial is for healthy individuals who can participate in a study to evaluate how LY4100511 (DC-853) affects the body's processing of certain drugs. Specific eligibility criteria are not provided, but typically participants must be free from any significant health issues.
What is being tested?
The study is testing the effects of two doses of LY4100511 (DC-853) on how the body breaks down drugs processed by liver enzymes CYP3A4 and CYP2C8. It will compare these effects when LY4100511 is taken alone versus with repaglinide or midazolam.
What are the potential side effects?
While specific side effects are not listed, safety and tolerability suggest monitoring for common drug-related adverse reactions such as headaches, nausea, dizziness, or allergic reactions during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman capable of becoming pregnant.
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My BMI is between 18.0 and 32.0, and I weigh at least 50 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have tested positive for active or latent TB.
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My heart's electrical activity is normal and doesn't pose risks for study participation.
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I haven't had surgery in the last 12 weeks and don't plan to during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3)Experimental Treatment3 Interventions
Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin.
Group II: LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2)Experimental Treatment3 Interventions
Participants will receive up to an oral dose 2 of LY4100511 and single dose of midazolam and repaglinide. Dosing will not proceed until a satisfactory review of the safety and tolerability data from lower dose level is performed.
Group III: LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1)Experimental Treatment3 Interventions
Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digoxin
2017
Completed Phase 4
~670
Rosuvastatin
2019
Completed Phase 4
~3150
Midazolam
2018
Completed Phase 4
~1910
Repaglinide
2016
Completed Phase 4
~7010

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyLead Sponsor
8 Previous Clinical Trials
661 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,381 Previous Clinical Trials
424,264 Total Patients Enrolled
~19 spots leftby Dec 2024
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