A Phase 1, Single-center, Open-label, Fixed-sequence, Crossover Study to Evaluate the Effect of LY4100511 (DC-853) on the Single-dose Pharmacokinetics of Midazolam, Repaglinide, Digoxin, and Rosuvastatin in Healthy Participants
| Registry | NCT06503679 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, basic science |
| Enrollment | 49 (Actual) |
| Sponsor | DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company (Industry) |
| Conditions | Healthy |
| Interventions | LY4100511 (DC-853) Dose 1, LY4100511 (DC-853) Dose 2, LY4100511 (DC-853) Dose 3, Midazolam, Repaglinide, Digoxin, Rosuvastatin (Drug) |
| Dates | start 2024-07-16, primary completion 2024-12-31, completion 2024-12-31, first posted 2024-07-16, last updated 2025-01-24 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of LY4100511 (DC-853) Dose 1 All trials of LY4100511 (DC-853) Dose 2
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1) | Experimental | Drug: LY4100511 (DC-853) Dose 1; Drug: Midazolam; Drug: Repaglinide | Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide. |
| LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) | Experimental | Drug: LY4100511 (DC-853) Dose 2; Drug: Midazolam; Drug: 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 3 + Digoxin and Rosuvastatin (Cohort 3) | Experimental | Drug: LY4100511 (DC-853) Dose 3; Drug: Digoxin; Drug: Rosuvastatin | Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin. |
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
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| Facility | City | Country | Status |
|---|---|---|---|
| Fortrea Clinical Research Unit | Dallas, Texas | United States |