Healthy Participants
Conditions
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.
Interventions
DRUGLY4100511
Administered orally.
DRUGRabeprazole
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed