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

NCT06503679 — Phase 1, Completed, 49 participants, DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT06503679
StatusCompleted
PhasePhase 1
Study typeInterventional; non randomized, parallel, masking: none, basic science
Enrollment49 (Actual)
SponsorDICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company (Industry)
ConditionsHealthy
InterventionsLY4100511 (DC-853) Dose 1, LY4100511 (DC-853) Dose 2, LY4100511 (DC-853) Dose 3, Midazolam, Repaglinide, Digoxin, Rosuvastatin (Drug)
Datesstart 2024-07-16, primary completion 2024-12-31, completion 2024-12-31, first posted 2024-07-16, last updated 2025-01-24
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of LY4100511 (DC-853) Dose 1 All trials of LY4100511 (DC-853) Dose 2

-Summary

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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1)ExperimentalDrug: LY4100511 (DC-853) Dose 1; Drug: Midazolam; Drug: RepaglinideParticipants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide.
LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2)ExperimentalDrug: LY4100511 (DC-853) Dose 2; Drug: Midazolam; Drug: RepaglinideParticipants 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.
LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3)ExperimentalDrug: LY4100511 (DC-853) Dose 3; Drug: Digoxin; Drug: RosuvastatinParticipants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin.
  • 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

+Outcome measures

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 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • 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 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • 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 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • 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 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • 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 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • 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 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • 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 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • 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 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • PK: Maximum Observed Concentration (Cmax) of Midazolam, in the absence or presence of steady-state LY4100511 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • PK: Maximum Observed Concentration (Cmax) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • PK: Maximum Observed Concentration (Cmax) of Repaglinide, in the absence or presence of steady-state LY4100511 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]
  • PK: Maximum Observed Concentration (Cmax) of Digoxin, in the absence or presence of steady-state LY4100511 [Day 1 and Day 9: Predose, Up to 48 Hours Post Dose]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, 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

+Locations (1)

FacilityCityCountryStatus
Fortrea Clinical Research UnitDallas, TexasUnited States

+Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company