LY4100511 Absorption Study

Recruiting at 1 trial location

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must be taking: Proton pump inhibitors

Disqualifiers: ECG abnormalities, Recent infection, Malignancy, IBD

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

Compensation: Varies

Number of Visits: Unknown

Duration: 26 days

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves testing the effect of a proton pump inhibitor (PPI), you may need to discuss your current medications with the study team.

What is the purpose of this trial?

The main purpose of this study is to compare the bioavailability of 3 different formulations of LY4100511 and if the use of a proton pump inhibitor (PPI) alters the bioavailability of the 3 different formulations.

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

Eligibility Criteria

This trial is for healthy individuals who are interested in helping to test how the body absorbs three different versions of a drug called LY4100511. Participants should not have any significant health issues that could interfere with the study.

Inclusion Criteria

My BMI is between 18 and 32, and I weigh at least 50 kg.

I am in good health with no significant medical issues found in recent tests.

Exclusion Criteria

Have a 12-lead ECG abnormality that increases the risk associated with participating in the study, may confound ECG data analysis, or meets specific criteria such as QTcF, PR interval, atrioventricular block, intraventricular conduction delay, bundle branch blocks, or Wolff Parkinson-White syndrome

I have inflammatory bowel disease, such as ulcerative colitis or Crohn's disease.

I currently have or recently had a serious infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive different formulations of LY4100511 with and without Rabeprazole to assess bioavailability

26 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY4100511
• Rabeprazole

Trial Overview The study is looking at how well the body takes up three forms of LY4100511, both on their own and when taken with Rabeprazole, a medication that lowers stomach acid. The goal is to see if Rabeprazole affects this process.

Participant Groups

Group I: LY4100511 (DC-853) + Rabeprazole - Test 2 Experimental Treatment 2 Interventions

LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole

Group II: LY4100511 (DC-853) + Rabeprazole - Test 1 Experimental Treatment 2 Interventions

LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole.

Group III: LY4100511 (DC-853) + Rabeprazole - Reference Experimental Treatment 2 Interventions

LY4100511 (DC-853) administered orally alone then LY4100511 (DC-853) administered orally with Rabeprazole.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University