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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIBA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evacetrapib Reference (R) | Experimental | Single oral dose of 130 mg evacetrapib tablet given one time during one study period. |
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| Evacetrapib Test 1 (T1) | Experimental | Single oral dose of 130 mg evacetrapib tablet given one time during one study period. |
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| Evacetrapib Test 2 (T2) | Experimental | Single oral dose of 130 mg evacetrapib tablet given one time during one study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib | Predose on Day 1,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 | |
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib | Predose on Day 1,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 |
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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. | Singapore | 117597 |
Participants were randomized to 1 of 6 treatment sequences in a crossover design with 3 treatments; reference, test 1 and test 2. There was a washout period of ≥14 days between each dose. Participants were dosed 3 times during the entire study in periods 1, 2 and 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 (R/T1/T2) | Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: R Period 2: T1 Period 3: T2 |
| FG001 | Sequence 2 (T1/T2/R) | Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1(T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: T1 Period 2: T2 Period 3: R |
| FG002 | Sequence 3 (T2/R/T1) | Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: T2 Period 2: R Period 3: T1 |
| FG003 | Sequence 4 (T2/T1/R) | Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: T2 Period 2: T1 Period 3: R |
| FG004 | Sequence 5 (R/T2/T1) | Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: R Period 2: T2 Period 3: T1 |
| FG005 | Sequence 6 (T1/R/T2) | Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation. All participants received one tablet in Period 1: T1 Period 2: R Period 3: T2 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (14 Days) |
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| Period 2 (14 Days) |
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| Period 3 (14 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Participants received a single dose of 130 mg evacetrapib tablet (a total of 3 doses of evacetrapib) given one time during each study period. |
| 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 Observed Concentration (Cmax) of Evacetrapib | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nangram/milliliter (ng/mL) | Predose on Day 1,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 |
|
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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 | Evacetrapib Reference (R) | Single oral dose of evacetrapib 130 mg tablet given one time during one study period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site related reaction | General disorders | MedDRA 18.0 | 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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| Singapore |
| 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 | 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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| OG002 |
| Evacetrapib Test 2 (T2) |
Single oral dose of evacetrapib 130 mg tablet given one time during one study period. |
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram·hour/milliter (ng·h/mL) | Predose on Day 1,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 |
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|
|
| 0 |
| 84 |
| 33 |
| 84 |
| EG001 | Evacetrapib Test 1 (T1) | Single oral dose of evacetrapib 130 mg tablet given one time during one study period. | 0 | 81 | 22 | 81 |
| EG002 | Evacetrapib Test 2 (T2) | Single oral dose of evacetrapib 130 mg tablet given one time during one study period. | 0 | 85 | 23 | 85 |
| Vessel puncture site bruise | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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