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

DICE Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Digoxin; Drug: Repaglinide; Drug: LY4100511 (DC-853) Dose 3; Drug: Midazolam; Drug: Rosuvastatin; Drug: LY4100511 (DC-853) Dose 1; Drug: LY4100511 (DC-853) Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06503679

J5C-MC-FOAF, DC-853104 (Other Identifier)

27110

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 3 patient groups

LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1)

Experimental group

Description:

Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide.

Treatment:

Drug: LY4100511 (DC-853) Dose 1

Drug: Midazolam

Drug: Repaglinide

LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2)

Experimental group

Description:

Participants will receive up to an oral dose 2 of LY4100511 and single dose of midazolam and repaglinide. Dosing will not proceed until a satisfactory review of the safety and tolerability data from lower dose level is performed.

Treatment:

Drug: LY4100511 (DC-853) Dose 2

Drug: Midazolam

Drug: Repaglinide

LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3)

Experimental group

Description:

Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin.

Treatment:

Drug: Rosuvastatin

Drug: LY4100511 (DC-853) Dose 3

Drug: Digoxin