A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company49 enrolled

Overview

The main purpose of this study is to assess the safety and tolerability and pharmacokinetics of LY4100511 (DC-853) when administered alone or in the presence of cytochrome P450 substrates in healthy participants.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

LY4100511 (DC-853) Dose 1DRUG

Administered orally

LY4100511 (DC-853) Dose 2DRUG

Administered orally

LY4100511 (DC-853) Dose 3DRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Females must be of childbearing potential * Males must agree to use contraception * Have body mass index (BMI) between 18.0 and 32.0 kilogram/square meter (kg/m²), inclusive, and a body weight of greater than or equal to 50 kg. * In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clincial laboratory evaluations (congentical nonhemolytic hyperbilirubinemia) at screening and check-in, and from the physical examination at check-in as assessed by the investigator. Exclusion Criteria: * Have a 12-lead ECG abnormality that, in the opinion of the investigator, * increases the risks associated with participating in the study * may confound ECG data analysis * a QTCF \>450 msec for males, or \>470 msec for females * short PR interval \<120 msec or PR interval \>220 msec * second or third degree atrioventricular block * intraventricular conduction delay with QRS \>120 msec * complete right bundle branch block * left bundle branch block, or * Wolff Parkinson-White syndrome. * Have had current or recent acute infection * Show evidence of active or latent tuberculosis (TB) * Had any surgical procedures within 12 weeks prior to screening or any planned surgical procedure scheduled to occur during the study. * Have a history or presence of multiple or severe allergies, or an anaphylactic reaction to prescription or non prescription drugs. * Are immunocompromised * Presence of active suicidal ideation or positive suicide behavior using baseline/screening version of the C-SSRS

Locations (1)

Fortrea Clinical Research Unit

Dallas, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Midazolam, in the absence or presence of steady-state LY4100511