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| ID | Type | Description | Link |
|---|---|---|---|
| J3M-OX-JZQD | 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 the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3537982 + Itraconazole (Part 1) | Experimental | LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally. |
|
| LY3537982 + Carbamazepine (Part 2) | Experimental | LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3537982 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole | PK: Cmax of LY3537982 administered with or without itraconazole | Predose on day 1 up to 72 hours postdose on day 9 |
| PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole | PK: AUC[0-inf] of LY3537982 administered with or without itraconazole | Predose on day 1 up to 72 hours postdose on day 9 |
| PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole | PK: AUClast of LY3537982 administered with or without itraconazole | Predose on day 1 up to 72 hours postdose on day 9 |
| PK: Cmax of LY3537982 administered with or without carbamazepine | PK: Cmax of LY3537982 administered with or without carbamazepine | Predose on day 1 up to 72 hours postdose on day 13 |
| PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine | PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine | Predose on day 1 up to 72 hours postdose on day 13 |
| PK: AUClast of LY3537982 administered with or without carbamazepine | PK: AUClast of LY3537982 administered with or without carbamazepine | Predose on day 1 up to 72 hours postdose on day 13 |
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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 |
|---|---|---|---|---|---|---|
| ICON Early Development Services | San Antonio | Texas | 78209 | United States | ||
| ICON Early Development Services |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Administered orally. |
|
| Carbamazepine | Drug | Administered orally. |
|
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| D010879 |
| Piperazines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |