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

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Rabeprazole; Drug: LY4100511

Study type: Interventional

Funder types: Industry

Identifiers

NCT06916143

J5C-MC-FOAH, DCE853105 (Other Identifier)

27274

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

LY4100511 (DC-853) + Rabeprazole - Reference

Experimental group

Description:

LY4100511 (DC-853) administered orally alone then LY4100511 (DC-853) administered orally with Rabeprazole.

Treatment:

Drug: LY4100511

Drug: Rabeprazole

LY4100511 (DC-853) + Rabeprazole - Test 1

Experimental group

Description:

LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole.

Treatment:

Drug: LY4100511

Drug: Rabeprazole

LY4100511 (DC-853) + Rabeprazole - Test 2

Experimental group

Description:

LY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole

Treatment:

Drug: LY4100511

Drug: Rabeprazole