Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Availab… (NCT06916143) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
United States48 participantsStarted 2025-04-08
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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,…
What they're measuring
1
Pharmacokinetic (PK): Area Under the Concentration Curve from 0 to Infinity (AUC0-∞) of LY4100511 (DC-853)
Timeframe: Predose up to 26 Days
2
Pharmacokinetic (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)
Timeframe: Predose up to 26 Days
3
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)