Healthy ParticipantsPhase 1NCT06916143

Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid

A Phase 1 study testing LY4100511 and Rabeprazole in people with Healthy Participants, run by Eli Lilly and Company at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: LY4100511 and Rabeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 2 sitesUnited States
Study dates: 8 Apr 2025to 8 Apr 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index between 18.0 and 32.0 kilograms per meter squared (kg/m2), inclusive, and a body weight of ≥50 kg.
In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG) and vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in, and from the physical examination at check-in, as assessed by the Investigator (or designee).

Who cannot join

Have a 12-lead ECG abnormality that, in the opinion of the Investigator,
increases the risk associated with participating in the study
may confound ECG data analysis
a QTcF: >450 millisecond (msec) for males, or >470 msec for females
short PR interval <120 msec or PR interval >220 msec
second or third degree atrioventricular block

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intraventricular conduction delay with QRS >120 msec
complete right bundle branch block
left bundle branch block, or
Wolff Parkinson-White syndrome
Have a current or recent acute, active infection (for example, for a least 30 days before screening and up to Day -1, participants must have no symptoms or signs of infection in the absence of any anti-infective treatment).
Had any malignancy within the past 5 years. Exceptions: successfully treated basal cell skin carcinoma or squamous cell skin carcinoma, with no evidence of recurrence or metastatic disease within the 3 years prior to baseline.
Have inflammatory bowel disease (IBD), including ulcerative colitis or Crohn's disease.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
Clinical Pharmacology of Miami
Miami, Florida, 33172

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, Four-way Crossover Study to Assess the Relative Bioavailability of Two Phase 3 LY4100511 (DC-853) Tablet Formulations Compared With the Phase 2 LY4100511(DC-853) Tablet Formulation, With and Without a Proton Pump Inhibitor in Healthy Participants

Conditions: Healthy Participants
Being tested: LY4100511, Rabeprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY4100511Drug
Administered orally.
RabeprazoleDrug
Administered orally.

Study groups in NCT06916143
Study group	Role	What they receive
LY4100511 (DC-853) + Rabeprazole - Reference	Experimental	LY4100511 (DC-853) administered orally alone then LY4100511 (DC-853) administered orally with Rabeprazole. Receives: Drug: LY4100511; Drug: Rabeprazole
LY4100511 (DC-853) + Rabeprazole - Test 1	Experimental	LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole. Receives: Drug: LY4100511; Drug: Rabeprazole
LY4100511 (DC-853) + Rabeprazole - Test 2	Experimental	LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole Receives: Drug: LY4100511; Drug: Rabeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic (PK): Area Under the Concentration Curve from 0 to Infinity (AUC0-∞) of LY4100511 (DC-853)
PK: AUC0-∞ of LY4100511
Measured: Predose up to 26 Days
Pharmacokinetic (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)
PK: Cmax of LY4100511 (DC-853)
Measured: Predose up to 26 Days
Pharmacokinetic (PK): Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-T) of LY4100511 (DC-853)
PK: AUC0-T of LY4100511 (DC-853)
Measured: Predose up to 26 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 20258 Apr 2025

First posted8 Apr 2025
Study start8 Apr 2025
Primary completion8 Apr 2025
Study completion8 Apr 2025

Why it stopped: Original scientific question rendered moot by the external scientific community

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06916143
Sponsor's protocol ID: 27274
Other IDs: J5C-MC-FOAH, DCE853105
Status last verified: Aug 2026
First submitted: 2 Apr 2025
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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