Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIAX | 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
The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.
The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.
This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evacetrapib (Fasted) | Experimental | 130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days. |
|
| Evacetrapib (Fed) | Experimental | 130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose | |
| PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
Not provided
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. | Daytona Beach | Florida | 32117 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 (Fast/Fed) | Participants received a 130 milligram (mg) oral tablet of evacetrapib once daily (QD) for 10 days (Period 1) in a fasted state. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast. |
| FG001 | Sequence 2 (Fed/Fasted) | Participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Washout |
| ||||||||||||||||
| Period 2 |
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Evacetrapib | Sequence 1-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) in a fasted state. Following a 14-day washout period, participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast. Sequence 2-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state. |
| 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): Maximum Concentration (Cmax) of Evacetrapib | All participants with evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
|
Not provided
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
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 | Evacetrapib (Fasted) | Participants received 130-mg oral tablet fo evacetrapib QD in a fasted state for 10 days. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| C568301 | evacetrapib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| High-fat Meal | Other | Administered orally, at breakfast. |
|
| United States |
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib | All participants with evaluable AUCτ data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
|
|
|
| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | All participants with evaluable tmax data. | Posted | Median | Full Range | hours (h) | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
|
|
|
| 0 |
| 39 |
| 7 |
| 39 |
| EG001 | Evacetrapib (Fed) | Participants received 130-mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days. | 0 | 39 | 4 | 39 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.