LY4100511 for Healthy Subjects

Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

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

No Placebo Group

Trial Summary

What is the purpose of this trial?The main purpose of this study is to assess the safety and tolerability and pharmacokinetics of LY4100511 (DC-853) when administered alone or in the presence of cytochrome P450 substrates in healthy participants.

Eligibility Criteria

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.

Inclusion Criteria

I am a woman capable of becoming pregnant.

My BMI is between 18.0 and 32.0, and I weigh at least 50 kg.

Exclusion Criteria

I have tested positive for active or latent TB.

My heart's electrical activity is normal and doesn't pose risks for study participation.

I haven't had surgery in the last 12 weeks and don't plan to during the study.

Treatment Details

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.

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.