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OpenTrials
Completed

NCT Number: NCT06345794

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON San Antonio Clinical Research Unit

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4100511 (DC-853)

Drug

Administered orally.

Other names: DC-853

Itraconazole

Drug

Administered orally.

Fluconazole

Drug

Administered orally.

carbamazepine

Drug

Administered orally.

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)

    Time frame: Predose up to 26 Days

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2024
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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