LY4100511 for Healthy Subjects

Recruiting at 1 trial location

Overseen By This is a single site in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Disqualifiers: ECG abnormalities, Recent infection, Tuberculosis, Immunocompromised, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

49 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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 in good health with no significant medical issues.

I am a woman capable of becoming pregnant.

I agree to use birth control.

Exclusion Criteria

Presence of active suicidal ideation or positive suicide behavior using baseline/screening version of the C-SSRS

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

I have tested positive for active or latent TB.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4100511 in combination with cytochrome P450 substrates to assess pharmacokinetics and safety

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4100511 (DC-853)

Trial Overview 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.

How Is the Trial Designed?

Group I: LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) Experimental Treatment 3 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 Treatment 3 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 Treatment 3 Interventions

Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

10

Recruited

810+