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| ID | Type | Description | Link |
|---|---|---|---|
| J3P-MC-FTAD | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the effect of LY3871801 when administered orally on the levels of methotrexate (part 1), drug cocktail (warfarin, dextromethorphan, and midazolam) and repaglinide (part 2) in the blood stream when administered orally in healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3871801 will also be evaluated. The study may last up to approximately 25 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3871801 + Methotrexate (Part 1) | Experimental | LY3871801 administered orally in combination with methotrexate given orally. |
|
| LY3871801 + Repaglinide + Drug Cocktail (Part 2) | Experimental | LY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3871801 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Methotrexate | Part 1: PK: Cmax of Methotrexate | Predose up to 48 hours postdose |
| Part 1: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Methotrexate | Part 1: PK: AUC[0-∞] of Methotrexate | Predose up to 48 hours postdose |
| Part 2: PK: Cmax of Midazolam | Part 2: PK: Cmax of Midazolam | Predose up to 24 hours postdose |
| Part 2: PK: AUC[0-∞] of Midazolam | Part 2: PK: AUC[0-∞] of Midazolam | Predose up to 24 hours postdose |
| Part 2: PK: Cmax of S-warfarin | Part 2: PK: Cmax of S-warfarin | Predose up to 96 hours postdose |
| Part 2: PK: AUC[0-∞] of S-warfarin | Part 2: PK: AUC[0-∞] of S-warfarin | Predose up to 96 hours postdose |
| Part 2: PK: Cmax of Dextromethorphan | Part 2: PK: Cmax of Dextromethorphan | Predose up to 72 hours postdose |
| Part 2: PK: AUC[0-∞] of Dextromethorphan | Part 2: PK: AUC[0-∞] of Dextromethorphan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Dallas | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D014859 | Warfarin |
| D003915 | Dextromethorphan |
| D008874 | Midazolam |
| C072379 | repaglinide |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Methotrexate | Drug | Administered orally. |
|
| Warfarin | Drug | Administered orally. |
|
| Dextromethorphan | Drug | Administered orally. |
|
| Midazolam | Drug | Administered orally. |
|
| Repaglinide | Drug | Administered orally. |
|
| Predose up to 72 hours postdose |
| Part 2: PK: Cmax of Repaglinide | Part 2: PK: Cmax of Repaglinide | Predose up to 24 hours postdose |
| Part 2: PK: AUC[0-∞] of Repaglinide | Part 2: PK: AUC[0-∞] of Repaglinide | Predose up to 24 hours postdose |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |