RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-08

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06916143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

3176154559

clinical_inquiry_hub@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Clinical Pharmacology of Miami

Miami, Florida, 33172

United States

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-08

Study Completion Date2025-06

Study Record Updates

Study Start Date2025-04-08

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Healthy Participants