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| ID | Type | Description | Link |
|---|---|---|---|
| J4C-OX-JZUE | 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 evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 ([¹⁴C]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and [¹⁴C]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [¹⁴C]-LOXO-783 (Part 1) | Experimental | Single dose of [¹⁴C]-LOXO-783 administered orally |
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| LOXO-783 + [¹⁴C]-LOXO-783 (Part 2) | Experimental | Single dose of LOXO-783 administered orally followed by single dose of [¹⁴C]-LOXO-783 administered intravenously (IV) |
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| Name | Type | Description | Arm Group Labels | Other Names |
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| [¹⁴C]-LOXO-783 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur) | PK: Feur | Predose on day 1 up to postdose on day 21 (Part 1) |
| PK: Cumulative Feur | PK: Cumulative Feur | Predose on day 1 up to postdose on day 21 (Part 1) |
| PK: Fraction of Dose Excreted in Feces (Fefeces) | PK: Fefeces | Predose on day 1 up to postdose on day 21 (Part 1) |
| PK: Cumulative Fefeces | PK: Cumulative Fefeces | Predose on day 1 up to postdose on day 21 (Part 1) |
| PK: Fraction of Dose Excreted in Expired Air (Feair) | PK: Feair | Predose on day 1 up to postdose on day 21 (Part 1) |
| PK: Absolute Bioavailability (F) of LOXO-783 | PK: F of LOXO-783 | Predose on day 1 up to postdose on day 9 (Part 2) |
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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 |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research | Madison | Wisconsin | 53704 | United States |
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| LOXO-783 | Drug | Administered orally |
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| [¹⁴C]-LOXO-783 | Drug | Administered IV |
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