LY4100511 Absorption Study

Recruiting at 1 trial location

Overseen By Physicians interested in becoming principal investigators please contact

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well the body absorbs three different versions of the new drug, LY4100511, and whether Rabeprazole, a common acid-reducing medication, affects this absorption. Participants will receive the drug alone and then with Rabeprazole to compare results. Suitable candidates for this trial are generally healthy individuals with a body mass index (BMI) between 18.0 and 32.0. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LY4100511 is generally safe for both healthy individuals and those with conditions like plaque psoriasis. Previous studies examined the safety of LY4100511 when combined with other medications, such as itraconazole and fluconazole, and found it to be safe.

Regarding rabeprazole, a common medication for reducing stomach acid, some studies have reported possible side effects like sexual dysfunction, though these are uncommon.

When LY4100511 is used with rabeprazole, no major safety concerns have been identified. This trial is in its early stages, focusing primarily on determining the safety of LY4100511 and identifying the optimal dose. Early trials typically involve small groups to quickly detect any serious side effects. Overall, evidence suggests that LY4100511, whether used alone or with rabeprazole, is expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LY4100511 (DC-853) because it offers a novel approach to treatment by combining it with Rabeprazole. Unlike standard treatments that might not incorporate this combination, LY4100511 (DC-853) potentially enhances absorption and effectiveness when paired with Rabeprazole, a medication that reduces stomach acid. This unique combination could lead to improved therapeutic outcomes by ensuring better medication absorption in the digestive system. The innovative pairing could open new avenues for treating conditions where absorption is a challenge, potentially offering faster and more efficient results.

What evidence suggests that this trial's treatments could be effective?

Research has primarily focused on LY4100511 to assess its safety and tolerability in both healthy individuals and patients with conditions like plaque psoriasis. In studies involving individuals with moderate-to-severe plaque psoriasis, LY4100511 has shown promise in improving symptoms. The treatment was well-tolerated, with a strong emphasis on safety in these trials. While detailed efficacy data is still being collected, early studies suggest that LY4100511 could help manage symptoms in specific conditions. The current trial will investigate how the body absorbs LY4100511 when administered alone and in combination with Rabeprazole, which could affect its overall effectiveness. ^{1 2 5 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06311656

A Study to Evaluate Safety, Tolerability of LY4100511 (DC- ... The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian ...

2. clinicaltrials.eu clinicaltrials.eu/inn/ly4100511/

Ly4100511 – Application in Therapy and Current Clinical ... These studies aim to evaluate its safety, tolerability, and effectiveness in healthy individuals and patients with specific conditions like plaque psoriasis.

3. trials.lilly.com trials.lilly.com/en-US/trial/533216

A Study of LY4100511 (DC-853) in Adult Participants With ... The main purpose of this study is to assess the safety and efficacy of LY4100511 in adult participants with moderate-to-severe plaque psoriasis.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06345794

A Study to Assess LY4100511 (DC-853) in Healthy Adult ... A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06345794/a-study-to-assess-ly4100511-dc-853-in-healthy-adult-participants

A Study to Assess LY4100511 (DC-853) in Healthy Adult ... The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY ...

6. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-3-2025-5636f

LY4100511 Absorption Study This Phase 1 medical study run by Eli Lilly and Company is evaluating whether LY4100511 will have tolerable side effects & efficacy for patients with ...

7. sigma.larvol.com sigma.larvol.com/product.php?e1=303231&tab=newstrac

rabeprazole News Findings of this study suggest the presence of safety signals of PPI-induced sexual dysfunctions, such as erectile dysfunction, genital discomfort and oestrogen ...