Clinical trial NCT06345794: A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: DC-853
LY4100511
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2024-04-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)
timeFrame: Predose up to 26 Days
measure: PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853)
timeFrame: Predose up to 26 Days
measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853)
timeFrame: Predose up to 26 Days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON San Antonio Clinical Research Unit
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Contact Lilly at 1-800-LillyRx (1-800-545-5979)
role: STUDY_DIRECTOR
References: