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| ID | Type | Description | Link |
|---|---|---|---|
| J3M-OX-JZQJ | 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 effects of multiple doses of LY3537982 on the pharmacokinetics (PK) of digoxin (a P-glycoprotein [P-gp] substrate), rosuvastatin (a breast cancer resistance protein [BCRP)] substrate), and midazolam (a substrate of Cytochrome P450 3A4 [CYP3A4]) in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982 with or without single doses of digoxin, rosuvastatin, and midazolam. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 23 and 11 days for part 1 and part 2, respectively, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3537982 + Digoxin & Rosuvastatin (Part 1) | Experimental | Single oral doses of digoxin and rosuvastatin with or without multiple doses of LY3537982 administered orally |
|
| LY3537982 + Midazolam (Part 2) | Experimental | Single doses of midazolam administered either orally or intravenously (IV) with or without multiple doses of LY3537982 administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3537982 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 | Part 1: PK: Cmax of LY3537982 | Predose on day 11 up to day 17 |
| Part 1: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 | Part 1: PK: AUC[0-inf] of LY3537982 | Predose on day 11 up to day 17 |
| Part 1: PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 | Part 1: PK: AUClast of LY3537982 | Predose on day 11 up to day 17 |
| Part 1: PK: Cmax of Digoxin | Part 1: PK: Cmax of Digoxin | Predose on day 1 up to day 21 |
| Part 1: PK: AUC[0-inf] of Digoxin | Part 1: PK: AUC[0-inf] of Digoxin | Predose on day 1 up to day 21 |
| Part 1: PK: AUClast of Digoxin | Part 1: PK: AUClast of Digoxin | Predose on day 1 up to day 21 |
| Part 1: PK: Cmax of Rosuvastatin | Part 1: PK: Cmax of Rosuvastatin | Predose on day 1 up to day 21 |
| Part 1: PK: AUC[0-inf] of Rosuvastatin | Part 1: PK: AUC[0-inf] of Rosuvastatin |
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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 |
|---|---|---|---|---|---|---|
| ICON Early Clinical & Bioanalytical Solutions | Salt Lake City | Utah | 84124 | United States |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin | Drug | Administered orally |
|
| Rosuvastatin | Drug | Administered orally |
|
| Midazolam | Drug | Administered orally |
|
| Midazolam | Drug | Administered IV |
|
| Predose on day 1 up to day 21 |
| Part 1: PK: AUClast of Rosuvastatin | Part 1: PK: AUClast of Rosuvastatin | Predose on day 1 up to day 21 |
| Part 2: PK: Cmax of LY3537982 | Part 2: PK: Cmax of LY3537982 | Predose on day 4 up to day 11 |
| Part 2: PK: AUC[0-inf] of LY3537982 | Part 2: PK: AUC[0-inf] of LY3537982 | Predose on day 4 up to day 11 |
| Part 2: PK: AUClast of LY3537982 | Part 2: PK: AUClast of LY3537982 | Predose on day 4 up to day 11 |
| Part 2: PK: Cmax of Midazolam | Part 2: PK: Cmax of Midazolam | Predose on day 1 up to day 9 |
| Part 2: PK: AUC[0-inf] of Midazolam | Part 2: PK: AUC[0-inf] of Midazolam | Predose on day 1 up to day 9 |
| Part 2: PK: AUClast of Midazolam | Part 2: PK: AUClast of Midazolam | Predose on day 1 up to day 9 |
| Part 2: PK: Cmax of 1'-Hydroxymidazolam | Part 2: PK: Cmax of 1'-Hydroxymidazolam | Predose on day 1 up to day 9 |
| Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam | Part 2: PK: AUC[0-inf] of 1'-Hydroxymidazolam | Predose on day 1 up to day 9 |
| Part 2: PK: AUClast of 1'-Hydroxymidazolam | Part 2: PK: AUClast of 1'-Hydroxymidazolam | Predose on day 1 up to day 9 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |