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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-JE-EIAY | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body. The study will also explore the effect of a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evacetrapib (reference) | Experimental | Single oral dose of 1 tablet of evacetrapib on Day 1 of up to three of five periods |
|
| Evacetrapib (test) | Experimental | Single oral dose of 2 tablets of evacetrapib on Day 1 of up to three of five periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4 | |
| PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5 | |
| PK: AUC(0-∞)of Evacetrapib (Fasted and Fed) |
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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. | Fukuoka | 812-0025 |
Periods 1 to 4 participants are in the fasting state and Period 5 participants were fed a low fat meal. There were two fixed sequences for Test (T) and Reference (R) doses with each participant receiving 5 doses. There was a washout period of at least 21 days between doses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference/Test/Reference/Test/Test | Reference (R) dose is a single oral dose of one - 130 mg tablet of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Test (T) dose is a single oral dose of Test two - 65 mg tablets of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses. |
| FG001 | Test/Reference/Test/Reference/Reference | Test (T) dose is a single oral dose of two - 65 milligram (mg) tablets of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Reference (R) is a single oral dose of Reference (R) one - 130 mg tablet of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 Fasted State |
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| Washout Period 1 (at Least 21 Days) |
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| Treatment Period 2 Fasted State |
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| Washout Period 2 (at Least 21 Days) |
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| Treatment Period 3 Fasted State |
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| Washout Period 3 (at Least 21 Days) |
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| Treatment Period 4 Fasted State |
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| Washout Period 4 (at Least 21 Days) |
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| Treatment Period 5 Fed State |
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| Washout Period 5 (at Least 21 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reference/Test/Reference/Test/Test | Reference(R) dose is a single oral dose of Reference 1 one- 130 mg tablet of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Then, Test (T) dose is a single oral dose of Test 2 two- 65 mg tablets of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses. |
| 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): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted) | All randomized participants who completed and had evaluable AUC(0-∞) bioequivalence fasted state data for Periods 1,2,3 and 4. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram·hour/milliliter (ng·h/mL) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4 |
|
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The safety population includes all 48 participants who enrolled in the study.
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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 | 130 mg Tablet Evacetrapib (Fasted) | Reference dose is a single oral dose of Reference one- 130 mg tablets of evacetrapib in fasted state in Periods 1, 2, 3, and 4. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | 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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| Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5 |
| PK: Cmax of Evacetrapib (Fasted and Fed) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5 |
| Japan |
| 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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| 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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| NOT COMPLETED |
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| BG001 | Test/Reference/Test/Reference/Reference | Test (T) dose is a single oral dose of Test 2 two- 65 mg tablets of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Then, Reference (R) dose is a single oral dose of Reference 1 one- 130 mg tablet of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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|
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| Primary | PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted) | All randomized participants who completed and had evaluable Cmax bioequivalence fasted state data for Periods 1,2,3 and 4. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/ml) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4 |
|
|
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| Secondary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed) | All randomized participants who completed and had evaluable Tmax Fasted and Fed State data for Periods 2, 4, and 5. | Posted | Median | Full Range | hour (h) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5 |
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|
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| Secondary | PK: AUC(0-∞)of Evacetrapib (Fasted and Fed) | All randomized participants who completed and had evaluable AUC(0-∞) Fasted and Fed State data for Periods 2,4, and 5. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5 |
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|
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| Secondary | PK: Cmax of Evacetrapib (Fasted and Fed) | All randomized participants who completed and had evaluable Cmax Fasted and Fed State data for Periods 2,4, and 5. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5 |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | 2 x 65 mg Tablets Evacetrapib (Fasted) | Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3, and 4. | 0 | 48 | 2 | 48 |
| EG002 | 130 mg Tablet Evacetrapib (Fed) | Reference dose is a single oral dose of Reference one- 130 mg tablets of in fed state in Period 5. | 0 | 23 | 0 | 23 |
| EG003 | 2 x 65 mg Tablets Evacetrapib (Fed) | Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5. | 0 | 23 | 2 | 23 |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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