A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants

March 28, 2024 updated by: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

A Phase 1, Single-Center, Open-Label, 3-Cohort, Fixed-Sequence, Drug-Drug Interaction Study To Assess The Pharmacokinetics Of LY4100511 (DC-853) When Orally Administered Alone, When Coadministered With Itraconazole, Fluconazole, Or Carbamazepine In Healthy Adult Participants

The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

  • Name: This is a single site clinical trial 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 13176154559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • ICON San Antonio Clinical Research Unit
        • Contact:
          • Phone Number: 210-283-4500
        • Principal Investigator:
          • Chinonye Ogbonnaya-Odor

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:

  • Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²)
  • Males who agree to follow contraceptive requirements and women of not childbearing potential
  • Have body weight greater than or equal to (>=) 50 Kilograms at screening.
  • Must have a negative Interferon-Gamma Release Assays (IGRA) testing at screening
  • Must have been stopped all the prescribed medication at least 14 days prior to admission to the clinical site
  • Ability and willingness to abstain from alcohol, caffeine, and methylxanthine-containing beverages or food 2 days prior to admission to the clinical site
  • Abstain from any strenuous physical exercise from 4 days prior to admission and during confinement at the clinical site

Exclusion Criteria:

  • Have a history of relevant drug and/or food allergies, or sensitivity to medications used in the current study
  • Females participants who are currently breastfeeding
  • Have History of alcohol abuse or drug addiction
  • Unable to abstain from tobacco products within the 2 days prior to admission and during confinement at the clinical site
  • Have Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies
  • Consumption of any nutrients known to modulate CYP450 enzymes activity
  • Are immunocompromised
  • Have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette-Guérin within 28 days of screening or intend to receive them during the study
  • Have had any malignancy within the past 5 years

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 (DC-853) + Itraconazole
Single oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally.
Drug: Itraconazole
Administered orally.
Drug: LY4100511 (DC-853)
Administered orally.
Other Names:
  • DC-853
Experimental: LY4100511 (DC-853) + Fluconazole
Single oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally.
Drug: LY4100511 (DC-853)
Administered orally.
Other Names:
  • DC-853
Drug: Fluconazole
Administered orally.
Experimental: LY4100511 (DC-853) + Carbamazepine
Single oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.
Drug: Carbamazepine
Administered orally.
Drug: LY4100511 (DC-853)
Administered orally.
Other Names:
  • DC-853

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)
Time Frame: Predose up to 26 Days
Predose up to 26 Days
PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853)
Time Frame: Predose up to 26 Days
Predose up to 26 Days
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853)
Time Frame: Predose up to 26 Days
Predose up to 26 Days

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

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979), 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 (Estimated)

April 3, 2024

Primary Completion (Estimated)

June 17, 2024

Study Completion (Estimated)

June 17, 2024

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27111
  • J5C-MC-FOAG (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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