A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345794
• Other study ID #: DCE853103
• Secondary ID: J5C-MC-FOAG
• Status: Recruiting
• Phase: Phase 1
• Start date: April 3, 2024
• Est. completion date: June 17, 2024

Study information

• Verified date: May 2024
• Source: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
• Contact: This is a single site clinical trial 1-877-CTLILLY (1-877-285-45
• Phone: 13176154559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 17, 2024
• Est. primary completion date: June 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY4100511 (DC-853)
Administered orally.
• Itraconazole
Administered orally.
• Fluconazole
Administered orally.
• Carbamazepine
Administered orally.

Locations

Country	Name	City	State
United States	ICON San Antonio Clinical Research Unit	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)		Predose up to 26 Days
Primary	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
Primary	PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853)		Predose up to 26 Days