Healthy
Conditions
Keywords
LY4100511, DC-853
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.
Interventions
DRUGMidazolam
Administered orally
DRUGRepaglinide
Administered orally
DRUGDigoxin
Administered orally
DRUGRosuvastatin
Administered orally
DRUGLY4100511 (DC-853) Dose 1
Administered orally
DRUGLY4100511 (DC-853) Dose 2
Administered orally
DRUGLY4100511 (DC-853) Dose 3
Administered orally
Sponsors
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed