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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIAJ | Other Identifier | Eli Lilly and Company |
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The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and to compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese subjects, and first-generation Japanese subjects after receiving a single oral dose of LY2484595 in a fasted state, after eating a low-fat meal, and after eating a high-fat meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Fixed Sequence of Meal Conditions | Experimental | LY2484595 (evacetrapib): 200 milligrams (mg) of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast. |
|
| Cohort B: Comparison of Randomized Treatments | Experimental | LY2484595 (evacetrapib): 100 mg of LY2484595 administered orally as an RF tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as a SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2484595 Reference Formulation (RF) | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595 | Area under the concentration-time curve from time zero to infinity is presented. | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose |
| Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595 | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Data presented are the number of participants who experienced one or more drug-related AEs or any serious AEs. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | Baseline through completion of study (approximately 2 months) |
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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. | Glendale | California | 91206 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Fixed Sequence of Meal Conditions | LY2484595: 200 milligrams (mg) of LY2484595 administered orally, one time only, as a spray-dried solid dispersion-propyl gallate (SDSD-PG) tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast. |
| FG001 | Cohort B: Comparison of Randomized Treatments | LY2484595: 100 mg of LY2484595 administered orally as reference formulation (RF) tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as a SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period of at Least 14 Days |
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| Period 2 |
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| Washout of at Least 14 Days |
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| Period 3 |
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All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Fixed Sequence of Meal Conditions | LY2484595: 200 milligrams (mg) of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with no food. There was a washout of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with low-fat breakfast. There was another washout period of at least 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high-fat breakfast. |
| 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: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595 | Area under the concentration-time curve from time zero to infinity is presented. | All participants in Cohort A who received at least 1 dose of study drug with evaluable LY2484595 plasma concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | hours times nanograms per milliliter | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose |
|
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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 | LY2484595 100 mg RF | Cohort B: 100 mg of LY2484595 administered orally one time as an RF tablet with a low-fat breakfast |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 14.1 | 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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| LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG) | Drug | Administered orally |
|
|
| 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 |
|
|
| BG001 | Cohort B: Comparison of Randomized Treatments | LY2484595: 100 mg of LY2484595 administered orally as an RF tablet given with a low-fat breakfast. There was a washout period of at least 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as an SDSD-PG tablet given with a low-fat breakfast. There was another washout of at least 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low-fat breakfast. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a low-fat breakfast
| OG002 | LY2484595 200 mg SDSD-PG High Fat | Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with a high-fat breakfast |
|
|
| Primary | Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595 | All participants in Cohort A who received at least 1 dose of study drug with evaluable LY2484595 maximum observed plasma concentration data | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose |
|
|
|
| Secondary | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Data presented are the number of participants who experienced one or more drug-related AEs or any serious AEs. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. | All participants who received at least 1 dose of study drug | Posted | Number | participants | Baseline through completion of study (approximately 2 months) |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | LY2484595 100 mg SDSD-PG | Cohort B: 100 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast. | 0 | 30 | 0 | 30 |
| EG002 | LY2484595 200 mg SDSD-PG | Cohort A: 200 mg of LY2484595 administered orally, one time only as an SDSD-PG tablet given with no food; then, after at least a 14 day washout period, 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with a low-fat breakfast; then, after a washout period of at least 14 days, 200 mg of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with a high-fat breakfast | 0 | 8 | 3 | 8 |
| EG003 | LY2484595 300 mg SDSD-PG | Cohort B: 300 mg of LY2484595 administered orally one time as an SDSD-PG tablet with a low-fat breakfast. | 0 | 31 | 4 | 31 |
| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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