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| ID | Type | Description | Link |
|---|---|---|---|
| J3M-OX-JZQE | 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 conduct blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in healthy participants. This study will involve a single dose of 14C radiolabeled LY3537982. This means that a radioactive tracer substance, C14, will be incorporated into the study drug LY3537982 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of LY3537982. The study will be conducted in two parts. The study will last up to 71 days and 61 days for part 1 and 2, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [¹⁴C]-LY3537982 (Part 1) | Experimental | Single dose of [¹⁴C]-LY3537982 administered orally. |
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| [¹⁴C]-LY3537982 + LY3537982 (Part 2) | Experimental | Single dose of LY3537982 administered orally followed by [¹⁴C]-LY3537982 administered intravenously (IV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3537982 | 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 LY3537982 | PK: F of LY3537982 | 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, MD, PhD | Loxo Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| [¹⁴C]-LY3537982 | Drug | Administered orally. |
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| [¹⁴C]-LY3537982 | Drug | Administered IV. |
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