A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: LY4100511 (DC-853) Dose 1Drug: LY4100511 (DC-853) Dose 2Drug: LY4100511 (DC-853) Dose 3
- Registration Number
- NCT06503679
- Lead Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
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
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Have a 12-lead ECG abnormality that, in the opinion of the investigator,
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increases the risks associated with participating in the study
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may confound ECG data analysis
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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.
-
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Have had current or recent acute infection
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Show evidence of active or latent tuberculosis (TB)
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Had any surgical procedures within 12 weeks prior to screening or any planned surgical procedure scheduled to occur during the study.
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Have a history or presence of multiple or severe allergies, or an anaphylactic reaction to prescription or non prescription drugs.
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Are immunocompromised
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Presence of active suicidal ideation or positive suicide behavior using baseline/screening version of the C-SSRS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) Digoxin Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin. LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) Rosuvastatin Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin. LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1) LY4100511 (DC-853) Dose 1 Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide. LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) LY4100511 (DC-853) Dose 2 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. LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) LY4100511 (DC-853) Dose 3 Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin. LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1) Midazolam Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide. LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1) Repaglinide Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide. LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) Repaglinide 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. LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) Midazolam 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit
🇺🇸Dallas, Texas, United States