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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Healthy Participants
Intervention / Treatment

-

Contacts and Locations

Miami

Clinical Pharmacology of Miami, Miami, Florida, United States, 33172

Knoxville

Alliance for Multispecialty Research, LLC, Knoxville, Tennessee, United States, 37920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2025-06