Status:
RECRUITING
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
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06916143
Start Date
April 8 2025
End Date
January 1 2026
Last Update
October 17 2025
Active Locations (2)
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1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33172
2
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States, 37920