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

Last updated: September 19, 2024
Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

1

Condition

N/A

Treatment

Fluconazole

LY4100511 (DC-853)

Itraconazole

Clinical Study ID

NCT06345794
DCE853103
J5C-MC-FOAG
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 childbearingpotential

  • 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 toadmission to the clinical site

  • Ability and willingness to abstain from alcohol, caffeine, andmethylxanthine-containing beverages or food 2 days prior to admission to theclinical site

  • Abstain from any strenuous physical exercise from 4 days prior to admission andduring confinement at the clinical site

Exclusion

Exclusion Criteria:

  • Have a history of relevant drug and/or food allergies, or sensitivity to medicationsused 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 andduring 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 BacillusCalmette-Guérin within 28 days of screening or intend to receive them during thestudy

  • Have had any malignancy within the past 5 years

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Fluconazole
Phase: 1
Study Start date:
April 03, 2024
Estimated Completion Date:
December 21, 2024

Connect with a study center

  • ICON San Antonio Clinical Research Unit

    San Antonio, Texas 78209
    United States

    Site Not Available

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