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

Launched by ELI LILLY AND COMPANY · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well three different forms of a medication called LY4100511 (also known as DC-853) are absorbed by the body. The researchers want to see if taking a medication that reduces stomach acid affects how much of LY4100511 gets into the bloodstream. The trial is open to healthy participants aged between 65 and 88 years, who have a body weight of at least 50 kg and a body mass index (BMI) between 18.0 and 32.0.

If you decide to participate, you can expect to undergo some health checks to ensure you are in good health, including tests on your heart and other vital signs. However, you won't be able to join if you have certain heart conditions, recent infections, or a history of certain cancers. This study is currently looking for volunteers, and your involvement could help researchers understand how this medication works, which may benefit others in the future.

Gender

ALL

Eligibility criteria

• 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.