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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT06503679

Run by

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

People needed

49

Starts

2024-07-16

Expected to finish

2024-12-31

Last updated by the study team

2025-01-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Fortrea Clinical Research Unit — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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