A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT06345794
- Run by
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
- People needed
- 50
- Starts
- 2024-04-03
- Expected to finish
- 2024-06-18
- Last updated by the study team
- 2025-04-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- ICON San Antonio Clinical Research Unit — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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