Comparing how different formulations of a drug are absorbed in the body with and without stomach acid reduction
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
This study tests how well different forms of a drug are absorbed in healthy people, both with and without a medication that reduces stomach acid.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT06916143 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the bioavailability of three different formulations of LY4100511 (DC-853) in healthy participants. It will also investigate whether the presence of a proton pump inhibitor, specifically Rabeprazole, affects the absorption of these formulations. Participants will undergo assessments to ensure they meet health criteria, and their responses will be monitored throughout the study. The findings could provide insights into optimizing drug formulations for better efficacy.
Who should consider this trial
Good fit: Ideal candidates are healthy adults with a body mass index between 18.0 and 32.0 kg/m2 and a body weight of at least 50 kg.
Not a fit: Patients with significant ECG abnormalities or those with conditions affecting drug absorption may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved drug formulations that enhance therapeutic effectiveness for patients.
How similar studies have performed: Other studies have shown success in evaluating drug formulations and their bioavailability, making this approach a continuation of established research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida and 1 other locations
- Clinical Pharmacology of Miami — Miami, Florida, United States (Recruiting)
- Alliance for Multispecialty Research, LLC — Knoxville, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 3176154559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.