A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06345794
- Lead Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY4100511 (DC-853) + Carbamazepine LY4100511 (DC-853) Single oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally. LY4100511 (DC-853) + Itraconazole LY4100511 (DC-853) Single oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally. LY4100511 (DC-853) + Fluconazole LY4100511 (DC-853) Single oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally. LY4100511 (DC-853) + Itraconazole Itraconazole Single oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally. LY4100511 (DC-853) + Fluconazole Fluconazole Single oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally. LY4100511 (DC-853) + Carbamazepine Carbamazepine Single oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ICON San Antonio Clinical Research Unit
🇺🇸San Antonio, Texas, United States