A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants

January 23, 2025 updated by: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

A Phase 1, Single-center, Open-label, Fixed-sequence, Crossover Study to Evaluate the Effect of LY4100511 (DC-853) on the Single-dose Pharmacokinetics of Midazolam, Repaglinide, Digoxin, and Rosuvastatin in Healthy Participants

The main purpose of this study is to assess the safety and tolerability and pharmacokinetics of LY4100511 (DC-853) when administered alone or in the presence of cytochrome P450 substrates in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Fortrea Clinical Research Unit

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Females must be of childbearing potential
  • Males must agree to use contraception
  • Have body mass index (BMI) between 18.0 and 32.0 kilogram/square meter (kg/m²), inclusive, and a body weight of greater than or equal to 50 kg.
  • In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clincial laboratory evaluations (congentical nonhemolytic hyperbilirubinemia) at screening and check-in, and from the physical examination at check-in as assessed by the investigator.

Exclusion Criteria:

  • Have a 12-lead ECG abnormality that, in the opinion of the investigator,

    • increases the risks associated with participating in the study
    • may confound ECG data analysis

    • a QTCF >450 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 had current or recent acute infection
  • Show evidence of active or latent tuberculosis (TB)
  • Had any surgical procedures within 12 weeks prior to screening or any planned surgical procedure scheduled to occur during the study.
  • Have a history or presence of multiple or severe allergies, or an anaphylactic reaction to prescription or non prescription drugs.
  • Are immunocompromised
  • Presence of active suicidal ideation or positive suicide behavior using baseline/screening version of the C-SSRS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1)
Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide.
Drug: Midazolam
Administered orally
Drug: LY4100511 (DC-853) Dose 1
Administered orally
Drug: Repaglinide
Administered orally
Experimental: LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2)
Participants will receive up to an oral dose 2 of LY4100511 and single dose of midazolam and repaglinide. Dosing will not proceed until a satisfactory review of the safety and tolerability data from lower dose level is performed.
Drug: Midazolam
Administered orally
Drug: Repaglinide
Administered orally
Drug: LY4100511 (DC-853) Dose 2
Administered orally
Experimental: LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3)
Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin.
Drug: Rosuvastatin
Administered orally
Drug: Digoxin
Administered orally
Drug: LY4100511 (DC-853) Dose 3
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Midazolam, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Repaglinide, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Digoxin, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Midazolam, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Repaglinide,in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Digoxin, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Midazolam, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Repaglinide, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Digoxin, in the absence or presence of steady-state LY4100511
Time Frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Investigators

  • Study Director: 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), 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 Major Dates

Study Start (Actual)

July 16, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27110
  • J5C-MC-FOAF, DC-853104 (Other Identifier: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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