Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIAO | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All study participants will receive both warfarin and a study drug called evacetrapib. The main 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 warfarin when given both with and without evacetrapib. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when given with evacetrapib by measuring the time it takes for blood to clot and comparing it to an average of the international normalized ratio (INR). INR measures the time it takes for blood to clot and compares it to an average.
The study will last approximately 5 weeks, not including screening.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin | Active Comparator | 15 milligrams (mg) warfarin administered as a single oral dose |
|
| Evacetrapib + Warfarin | Experimental | 130 mg evacetrapib administered once daily (QD), orally, for 16 days with 15 mg warfarin co-administered once orally on Day 10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | Oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of S-Warfarin | Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose | |
| PK: Maximum Observed Concentration (Cmax) of S-Warfarin | Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK: AUC0-∞ of R-Warfarin | Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose | |
| PK: Cmax of R-Warfarin | Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madison | Wisconsin | 53704 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 15 mg Warfarin | 15 milligram (mg) warfarin administered as a single oral dose on Day 1 |
| FG001 | 130 mg Evacetrapib + 15 mg Warfarin | 130 mg evacetrapib alone administered once daily (QD), orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
|
All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Participants were administered 15 mg warfarin as a single oral dose on Days 1 and 17; 130 mg evacetrapib was administered QD, orally, on Days 7 to 22. |
| 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): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of S-Warfarin | All participants who received a dose of study drug and had evaluable data for AUC(0-∞). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 15 mg Warfarin | 15 mg warfarin administered as a single oral dose on Day 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| C568301 | evacetrapib |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Warfarin | Drug | Oral administration |
|
| Pharmacodynamics (PD): Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin | The INR is a standardized ratio of the prothrombin time (PT), time it takes for blood to clot. AUCINR is the time curve used to measure change in INR over time. | Days 1 and 17: 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
| PD: Maximum Observed INR Response (INRmax) of Warfarin | The INR is a standardized ratio of the PT, time it takes for blood to clot. | 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose on Days 1 and 17 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of S-Warfarin | All participants who received a dose of study drug and had evaluable data for Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
|
|
|
| Secondary | PK: AUC0-∞ of R-Warfarin | All participants who received a dose of study drug and had evaluable data for AUC(0-∞). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
|
|
|
| Secondary | PK: Cmax of R-Warfarin | All participants who received a dose of study drug and had evaluable data for Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
|
|
|
| Secondary | Pharmacodynamics (PD): Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin | The INR is a standardized ratio of the prothrombin time (PT), time it takes for blood to clot. AUCINR is the time curve used to measure change in INR over time. | All participants who received a dose of study drug and had evaluable data for AUCINR. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio*h | Days 1 and 17: 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
|
|
|
| Secondary | PD: Maximum Observed INR Response (INRmax) of Warfarin | The INR is a standardized ratio of the PT, time it takes for blood to clot. | All participants who received a dose of study drug and had evaluable data for INRmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose on Days 1 and 17 |
|
|
|
| 0 |
| 17 |
| 5 |
| 17 |
| EG001 | 130 mg Evacetrapib | 130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 | 0 | 17 | 2 | 17 |
| EG002 | 130 mg Evacetrapib + 15 mg Warfarin | 130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17 | 0 | 16 | 4 | 16 |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Nail injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |