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Completed

NCT Number: NCT06503679

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4100511 (DC-853) Dose 1

Drug

Administered orally

LY4100511 (DC-853) Dose 2

Drug

Administered orally

LY4100511 (DC-853) Dose 3

Drug

Administered orally

midazolam

Drug

Administered orally

repaglinide

Drug

Administered orally

Digoxin

Drug

Administered orally

Rosuvastatin

Drug

Administered orally

Primary outcomes

  1. 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

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

  2. Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

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

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

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

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

  5. PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Midazolam, in the absence or presence of steady-state LY4100511

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

  6. PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

  7. PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Repaglinide,in the absence or presence of steady-state LY4100511

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

  8. PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Digoxin, in the absence or presence of steady-state LY4100511

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

  9. PK: Maximum Observed Concentration (Cmax) of Midazolam, in the absence or presence of steady-state LY4100511

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

  10. PK: Maximum Observed Concentration (Cmax) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

  11. PK: Maximum Observed Concentration (Cmax) of Repaglinide, in the absence or presence of steady-state LY4100511

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

  12. PK: Maximum Observed Concentration (Cmax) of Digoxin, in the absence or presence of steady-state LY4100511

    Time frame: Day 1 and Day 9: Predose, Up to 48 Hours Post Dose

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 1, Single-center, Open-label, Fixed-sequence, Crossover Study to Evaluate the Effect of LY4100511 (DC-853) on the Single-dose Pharmacokinetics of Midazolam, Repaglinide, Digoxin, and Rosuvastatin in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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