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| ID | Type | Description | Link |
|---|---|---|---|
| I8D-MC-AZEO | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to look at how much warfarin gets into the blood stream and how long it takes the body to get rid of it when given both with and without lanabecestat. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when given with lanabecestat by measuring international normalized ratio (INR). INR measures the time it takes for blood to clot and compares it to an average. Information about any side effects that may occur will also be collected. The study will last about 5 weeks from the first dose to follow-up for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin | Experimental | Single oral dose of 15 mg warfarin on Day 1. |
|
| Lanabecestat + Warfarin | Experimental | Lanabecestat administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanabecestat | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | |
| Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | |
| Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin |
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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 Clinical Research Inc | Evansville | Indiana | 47710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Warfarin | Single oral dose of 15 milligram (mg) warfarin on Day 1. |
| FG001 | LY3314814 + Warfarin | LY3314814 administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - Warfarin Single Dose |
| ||||||||||||||||
| Period 2 - LY3314814 and Warfarin |
|
Participants who received one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Overall study population. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Warfarin | Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal haemorrhage | Eye disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5079 |
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| ID | Term |
|---|---|
| C000608388 | lanabecestat |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Warfarin | Drug | Administered orally |
|
| Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22 |
| Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin | Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 |
| Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin | Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 |
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram * hour per milliliter(ng*h/mL) | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22 |
|
|
|
| Secondary | Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin | All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 |
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin | All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | LY3314814 | LY3314814 administered orally once daily on Days 8 to 27 LY3314814: Administered orally | 0 | 15 | 1 | 15 |
| EG002 | LY3314814 + Warfarin | Single oral dose of 15 mg warfarin co-administered on Day 22. LY3314814: Administered orally Warfarin: Administered orally | 0 | 15 | 1 | 15 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |