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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Midazolam

2018

Completed Phase 4

~1910

Repaglinide

2016