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| ID | Type | Description | Link |
|---|---|---|---|
| J6E-MC-KWAC | Other Identifier | Eli Lilly and Company | |
| MORF-057 | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese and Chinese participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4268989 or Placebo Cohort 1 (Blinded) | Experimental | Participants will receive LY4268989 orally or placebo single dose followed by BID administration |
|
| LY4268989 Cohort 2 (Open-Label) | Experimental | Participants will receive LY4268989 orally tablet (formulation compared to capsule formulation) in a fasted state |
|
| LY4268989 Cohort 3 (Open-Label) | Experimental | Participants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV). |
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| LY4268989 or Placebo Cohort 4 (Blinded) | Experimental | Participants will receive single escalating doses of LY4268989 orally or placebo |
|
| LY4268989 Cohort 5 (Blinded) | Experimental | Participants will receive multiple doses of LY4268989 orally or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4268989 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989 (Cohort 1) and (Cohort 5) | Day 1 to Day 17 | |
| PK: Area Under the Concentration Curve (AUC) of LY4268989 (Cohort 1) and (Cohort 5) | Day 1 to Day 17 | |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Cohort 1), (Cohort 3), and (Cohort 5) | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module | Baseline to Study Completion (Up to Day 17) |
| Number of Participants with TEAEs and SAEs (Cohort 4) | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module | Baseline to Study Completion (Up to Period 4, Day 4) |
| PK: Cmax of LY4268989 (Cohort 2) | Day 1 to Day 13 | |
| PK: AUC of LY4268989 (Cohort 2) | Day 1 to Day 13 | |
| PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 3) | PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989 | Day 1 to Day 17 |
| PK: AUC of Midazolam and 1'-Hydroxymidazolam (Cohort 8) | PK of midazolam and 1'-hydroxymidazolam (AUC), where midazolam is administered alone and in the presence of LY4268989 |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Cmax of LY4268989 (Cohort 4) | Day 1 to Day 4 | |
| PK: AUC of LY4268989 (Cohort 4) | Day 1 to Day 4 | |
| PK: Cmax of LY4268989 (Cohort 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel ACT | Anaheim | California | 92801 | United States |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Cohort 1, 4 and 5 are blinded while Cohort 2, 3, 6, 7, and 8 are open label.
| LY4268989 Cohort 6 (Open-Label) | Experimental | Participants will receive LY4268989 single dose orally in a fasted and fed state |
|
| LY4268989 Cohort 7 (Open-Label) | Experimental | Participants will receive multiple doses of LY4268989 orally BID administration in a fed state |
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| LY4268989 Cohort 8 (Open-Label) | Experimental | Participants will receive multiple doses of LY4268989 orally BID administration with midazolam IV in a fasted state. |
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| Placebo | Drug | Administered placebo |
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| Midazolam | Drug | Administered orally |
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| Midazolam | Drug | Administered intravenously (IV) |
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| Day 3 and Day 11 |
| PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 3) | PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989 | Day 1 to Day 17 |
| PK: Cmax of Midazolam and 1'-Hydroxymidazolam (Cohort 8) | PK of midazolam and 1'-hydroxymidazolam (Cmax), when midazolam is administered alone and in the presence of LY4268989 | Day 3 to Day 11 |
| PK: Cmax of LY4268989 (Cohort 6) | Day 1 to Day 7 |
| PK: AUC of LY4268989 (Cohort 6) | Day 1 to Day 7 |
| PK: Cmax of LY4268989 (Cohort 7) | Day 1 to Day 12 |
| PK: AUC of LY4268989 (Cohort 7) | Day 1 to Day 12 |
| Time Frame: Day 6 to Day 15 |
| PK: AUC of LY4268989 (Cohort 3) | Time Frame: Day 6 to Day 15 |
| PK: Cmax of LY4268989 (Cohort 8) | Time Frame: Day 3 and Day 10 |
| PK: AUC of LY4268989 (Cohort 8) | Time Frame: Day 3 and Day 10 |
| D006571 | Heterocyclic Compounds |