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

NCT06916143 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27274J5C-MC-FOAH, DCE853105
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic (PK): Area Under the Concentration Curve from 0 to Infinity (AUC0-∞) of LY4100511 (DC-853)

  PK: AUC0-∞ of LY4100511

  Predose up to 26 Days

• Pharmacokinetic (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)

  PK: Cmax of LY4100511 (DC-853)

  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)

  Predose up to 26 Days

Study Arms (3)

LY4100511 (DC-853) + Rabeprazole - Reference

EXPERIMENTAL

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

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.

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

Drug: LY4100511; Drug: Rabeprazole

Interventions

LY4100511 DRUG

Administered orally.

LY4100511 (DC-853) + Rabeprazole - Reference; LY4100511 (DC-853) + Rabeprazole - Test 1; LY4100511 (DC-853) + Rabeprazole - Test 2

Rabeprazole DRUG

Administered orally.

LY4100511 (DC-853) + Rabeprazole - Reference; LY4100511 (DC-853) + Rabeprazole - Test 1; LY4100511 (DC-853) + Rabeprazole - Test 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 8, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)