Status:
COMPLETED
A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants
Lead Sponsor:
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06503679
Start Date
July 16 2024
End Date
December 31 2024
Last Update
January 24 2025
Active Locations (1)
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1
Fortrea Clinical Research Unit
Dallas, Texas, United States, 75247