NCT06345794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2024

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

March 28, 2024

Last Update Submit

April 22, 2025

Conditions

Healthy

Keywords

DC-853LY4100511

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

LY4100511 (DC-853) + Itraconazole

EXPERIMENTAL

Single oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally.

Drug: LY4100511 (DC-853)Drug: Itraconazole

LY4100511 (DC-853) + Fluconazole

EXPERIMENTAL

Single oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally.

Drug: LY4100511 (DC-853)Drug: Fluconazole

LY4100511 (DC-853) + Carbamazepine

EXPERIMENTAL

Single oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.

Drug: LY4100511 (DC-853)Drug: Carbamazepine

Interventions

LY4100511 (DC-853)DRUG

Administered orally.

Also known as: DC-853
LY4100511 (DC-853) + CarbamazepineLY4100511 (DC-853) + FluconazoleLY4100511 (DC-853) + Itraconazole
ItraconazoleDRUG

Administered orally.

LY4100511 (DC-853) + Itraconazole
FluconazoleDRUG

Administered orally.

LY4100511 (DC-853) + Fluconazole
CarbamazepineDRUG

Administered orally.

LY4100511 (DC-853) + Carbamazepine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON San Antonio Clinical Research Unit

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

ItraconazoleFluconazoleCarbamazepine

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Contact Lilly at 1-800-LillyRx (1-800-545-5979)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

April 3, 2024

Primary Completion

June 18, 2024

Study Completion

June 18, 2024

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)