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| ID | Type | Description | Link |
|---|---|---|---|
| J5C-MC-FOAF, DC-853104 | Other Identifier | DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1) | Experimental | Participants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide. |
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| LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2) | Experimental | 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. |
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| LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3) | Experimental | Participants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4100511 (DC-853) Dose 1 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| 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 |
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Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Dallas | Texas | 75247 | United States |
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| LY4100511 (DC-853) Dose 2 | Drug | Administered orally |
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| LY4100511 (DC-853) Dose 3 | Drug | Administered orally |
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| Midazolam | Drug | Administered orally |
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| Repaglinide | Drug | Administered orally |
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| Digoxin | Drug | Administered orally |
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| Rosuvastatin | Drug | Administered orally |
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| 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 |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| C072379 | repaglinide |
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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