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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-08

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY4100511 (DC-853) + Rabeprazole - Reference

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

Group Type EXPERIMENTAL

LY4100511

Intervention Type DRUG

Administered orally.

Rabeprazole

Intervention Type DRUG

Administered orally.

LY4100511 (DC-853) + Rabeprazole - Test 1

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

Group Type EXPERIMENTAL

LY4100511

Intervention Type DRUG

Administered orally.

Rabeprazole

Intervention Type DRUG

Administered orally.

LY4100511 (DC-853) + Rabeprazole - Test 2

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

Group Type EXPERIMENTAL

LY4100511

Intervention Type DRUG

Administered orally.

Rabeprazole

Intervention Type DRUG

Administered orally.

Interventions

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LY4100511

Administered orally.

Intervention Type DRUG

Rabeprazole

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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, 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes