A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants
NCT ID: NCT06503679
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2024-07-16
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1)
Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide.
LY4100511 (DC-853) Dose 1
Administered orally
Midazolam
Administered orally
Repaglinide
Administered orally
LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 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 (DC-853) Dose 2
Administered orally
Midazolam
Administered orally
Repaglinide
Administered orally
LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3)
Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin.
LY4100511 (DC-853) Dose 3
Administered orally
Digoxin
Administered orally
Rosuvastatin
Administered orally
Interventions
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LY4100511 (DC-853) Dose 1
Administered orally
LY4100511 (DC-853) Dose 2
Administered orally
LY4100511 (DC-853) Dose 3
Administered orally
Midazolam
Administered orally
Repaglinide
Administered orally
Digoxin
Administered orally
Rosuvastatin
Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Fortrea Clinical Research Unit
Dallas, Texas, United States
Countries
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Other Identifiers
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J5C-MC-FOAF, DC-853104
Identifier Type: OTHER
Identifier Source: secondary_id
27110
Identifier Type: -
Identifier Source: org_study_id
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