Healthy
Conditions
Keywords
DC-853, LY4100511
Brief 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.
Interventions
Administered orally.
DRUGItraconazole
Administered orally.
DRUGFluconazole
Administered orally.
DRUGCarbamazepine
Administered orally.
Sponsors
Eli Lilly and Company
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853) | 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) | Predose up to 26 Days |
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853) | Predose up to 26 Days |
Countries
United States
Outcome results
None listed