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.
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
- Are there results?
- None posted in the registry
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
Show all 13Show fewer
- 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
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06916143
- Acronym / sponsor ID
- 27274
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original scientific question rendered moot by the external scientific community
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY4100511 (DC-853) + Rabeprazole - Reference | Experimental | Drug: LY4100511, Drug: RabeprazoleLY4100511 (DC-853) administered orally alone then LY4100511 (DC-853) administered orally with Rabeprazole. |
| LY4100511 (DC-853) + Rabeprazole - Test 1 | Experimental | Drug: LY4100511, Drug: RabeprazoleLY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole. |
| LY4100511 (DC-853) + Rabeprazole - Test 2 | Experimental | Drug: LY4100511, Drug: RabeprazoleLY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (13 listed)
- Have a 12-lead ECG abnormality that, in the opinion of the Investigator,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY4100511Administered orally. | Drug | LY4100511 (DC-853) + Rabeprazole - Reference, LY4100511 (DC-853) + Rabeprazole - Test 1, LY4100511 (DC-853) + Rabeprazole - Test 2 |
| RabeprazoleAdministered orally. | Drug | LY4100511 (DC-853) + Rabeprazole - Reference, LY4100511 (DC-853) + Rabeprazole - Test 1, LY4100511 (DC-853) + Rabeprazole - Test 2 |
Primary outcome
Pharmacokinetic (PK): Area Under the Concentration Curve from 0 to Infinity (AUC0-∞) of LY4100511 (DC-853)
Time frame: Predose up to 26 Days
PK: AUC0-∞ of LY4100511
Pharmacokinetic (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)
Time frame: Predose up to 26 Days
PK: Cmax of LY4100511 (DC-853)
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)
Time frame: Predose up to 26 Days
PK: AUC0-T of LY4100511 (DC-853)
Results and safety
The study was stopped early (reason given: Original scientific question rendered moot by the external scientific community). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Original scientific question rendered moot by the external scientific community). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (PK): Area Under the Concentration Curve from 0 to Infinity (AUC0-∞) of LY4100511 (DC-853) (time frame: Predose up to 26 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.