A Study to Assess LY4100511 (DC-853) 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.
Conditions:
🦠 Healthy
πŸ—“οΈ Study Start (Actual) 3 April 2024
πŸ—“οΈ Primary Completion (Estimated) 17 June 2024
βœ… Study Completion (Estimated) 17 June 2024
πŸ‘₯ Enrollment (Estimated) 50
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase PHASE1
Locations:
πŸ“ San Antonio, Texas, United States

πŸ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • * Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/mΒ²)
    • * 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-GuΓ©rin within 28 days of screening or intend to receive them during the study
    • * Have had any malignancy within the past 5 years
Ages Eligible for Study: 18 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

πŸ—“οΈ 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

  • First Submitted 28 March 2024
  • First Submitted that Met QC Criteria 28 March 2024
  • First Posted 3 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 May 2024
  • Last Update Posted 10 May 2024
  • Last Verified May 2024