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

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: LY4100511; Drug: Rabeprazole

• Registration Number: NCT06916143
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Study Start: 2025-04-08
• Study First Posted: 2025-04-08
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY4100511 (DC-853) + Rabeprazole - Reference	LY4100511	LY4100511 (DC-853) administered orally alone then LY4100511 (DC-853) administered orally with Rabeprazole.
LY4100511 (DC-853) + Rabeprazole - Reference	Rabeprazole	LY4100511 (DC-853) administered orally alone then LY4100511 (DC-853) administered orally with Rabeprazole.
LY4100511 (DC-853) + Rabeprazole - Test 1	LY4100511	LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole.
LY4100511 (DC-853) + Rabeprazole - Test 1	Rabeprazole	LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole.
LY4100511 (DC-853) + Rabeprazole - Test 2	LY4100511	LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole
LY4100511 (DC-853) + Rabeprazole - Test 2	Rabeprazole	LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole

Primary Outcome Measures

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

Trial Locations

Locations (2)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Knoxville, Tennessee, United States