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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIAU | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure and compare the amounts of the study drug evacetrapib found in the blood after taking two different formulations. The study has 3 periods. Participants will take each formulation by mouth at least once. A minimum of 14 days will pass between study drug doses. The safety and tolerability of the study drug will also be examined. Information about any side effects that may occur will also be collected. This study will last approximately 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evacetrapib -- Solid Fraction Test | Experimental | Single oral dose of 130 milligram (mg) evacetrapib tablet on Day 1 of up to 2 of 3 periods |
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| Evacetrapib -- Solid Fraction Reference | Experimental | Single oral dose of 130 mg evacetrapib tablet on Day 1 of up to 2 of 3 periods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595) | The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test). | Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595) | Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-∞]) is summarized for each solid fraction control (Reference and Test). | Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period |
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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 |
|---|---|---|---|---|---|---|
| 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. | Evansville | Indiana | 47710 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference/Test/Test | A single dose of Reference 130 mg evacetrapib on Day 1 of Period 1 and of Test 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3. There was a washout period of at least 14 days between doses. Each participant received up to 3 doses. |
| FG001 | Test/Reference/Reference | A single dose of Test 130 mg evacetrapib on Day 1 of Period 1 and of Reference 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3. There was a washout period of at least 14 days between doses. Each participant received up to 3 doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Washout Period 1 (at Least 14 Days) |
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| Treatment Period 2 |
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| Washout Period 1 (at Least 14 Days) |
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| Treatment Period 3 |
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All participants who received at last 1 dose of evacetrapib.
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| ID | Title | Description |
|---|---|---|
| BG000 | 130 mg Evacetrapib | Participants randomized to receive a single dose of 130 mg evacetrapib of either of the two different solid fraction controls on Day 1 of each of 3 treatment periods, according to their assigned treatment sequence. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Evacetrapib (LY2484595) | The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test). | Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period |
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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 | Reference | Evacetrapib: 130 mg with a solid fraction of 0.86 administered on Day 1 of up to 2 of 3 treatment periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C568301 | evacetrapib |
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| United States |
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | No |
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Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods.
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595) | Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-∞]) is summarized for each solid fraction control (Reference and Test). | Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms times hours per milliliter | Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period |
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|
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| 0 |
| 58 |
| 4 |
| 58 |
| EG001 | Test | Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods. | 0 | 59 | 1 | 59 |
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