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

DICE Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Carbamazepine; Drug: Itraconazole; Drug: LY4100511 (DC-853); Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06345794

DCE853103

J5C-MC-FOAG (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

LY4100511 (DC-853) + Itraconazole

Experimental group

Description:

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

Treatment:

Drug: Itraconazole

Drug: LY4100511 (DC-853)

LY4100511 (DC-853) + Fluconazole

Experimental group

Description:

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

Treatment:

Drug: Fluconazole

Drug: LY4100511 (DC-853)

LY4100511 (DC-853) + Carbamazepine

Experimental group

Description:

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

Treatment:

Drug: Carbamazepine

Drug: LY4100511 (DC-853)