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| ID | Type | Description | Link |
|---|---|---|---|
| I9Y-OX-JDHD | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Loxo Oncology, Inc. | INDUSTRY |
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The main purpose of this study is to assess the safety and tolerability of LY3410738 and to look at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 53 days, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Treatment A): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. |
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| Cohort 2 (Treatment B): LY3410738 | Placebo Comparator | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation. |
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| Cohort 3 (Treatment C): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
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| Cohort 4 (Treatment D): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
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| Cohort 5 (Treatment E): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3410738 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 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 through 53 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738 | PK: AUC0-24 of LY3410738 | Pre-dose up to 24 hours post-dose |
| PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingying Guo-Avrutin | Loxo Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Daytona Beach | Florida | 32117 | United States | ||
| Covance Clinical Research Unit |
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| Cohort 6 (Treatment F): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
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| Cohort 7 (Treatment G): LY3410738 | Experimental | Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation. |
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| Placebo | Drug | Administered orally. |
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PK: AUC0-t of LY3410738 |
| Pre-dose up to 48 hours post-dose |
| PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738 | PK: Cmax of LY3410738 | Pre-dose up to 48 hours post-dose |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738 | PK: Tmax of LY3410738 | Pre-dose up to 48 hours post-dose |
| Madison |
| Wisconsin |
| 53704 |
| United States |