Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIBN | 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 milligram (mg) warfarin administered as a single oral dose on Day 1 |
|
| Evacetrapib + Warfarin | Experimental | Evacetrapib administered once daily (QD), orally, for 16 days with 15 mg warfarin co-administered once orally on Day 17 |
|
| 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 (AUC[0-∞]) 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: AUC[0-∞] 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 | Warfarin | 15 milligram (mg) warfarin administered as a single oral dose on Day 1. |
| FG001 | Evacetrapib + Warfarin | Evacetrapib administered once daily (QD), orally, for 16 days on Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Day -1 to Day 7 Predose) |
| ||||||||||||||||
| Period 2 (Day 7 Dosing to Day 23) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Warfarin Then Evacetrapib + Warfarin | 15 mg warfarin administered as a single oral dose on Day 1. Evacetrapib administered QD, orally, for 16 days, Days 7- 22 with 15 mg warfarin co-administered once orally on Day 17. |
| 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 (AUC[0-∞]) 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 | nanogram*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 milligram (mg) warfarin administered as a single oral dose on Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | 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 (AUC[INR]) of Warfarin | The INR is a standardized ratio of the prothrombin time (PT), time it takes for blood to clot. AUC[INR] is the time curve used to measure change in INR over time. | Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
| PD: Maximum Observed International Normalized Ratio Response (INRmax) of Warfarin | Days 1 and 17: 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| 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 per 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: AUC[0-∞] 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 of R- enantiomers of Warfarin. | 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 (AUC[INR]) of Warfarin | The INR is a standardized ratio of the prothrombin time (PT), time it takes for blood to clot. AUC[INR] 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 AUC[INR]. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio times hour (ratio*h) | 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 | PD: Maximum Observed International Normalized Ratio Response (INRmax) of Warfarin | All participants who received a dose of study drug and had evaluable date for INRmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Days 1 and 17: 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 130 mg Evacetrapib | 130 mg Evacetrapib administered once daily (QD), orally, for 16 days, Days 7 - 22. | 0 | 24 | 2 | 24 |
| EG002 | 15 mg Warfarin + 130 mg Evacetrapib | Evacetrapib administered once daily (QD), orally, for 16 days, Days 7 - 22 with 15 milligram (mg) warfarin co-administered once orally on Day 17. | 0 | 23 | 0 | 23 |
Not provided
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |