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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIBM | Other Identifier | Eli Lilly and Company |
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The main 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 once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected.
This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evacetrapib: Single Dose | Experimental | Single oral dose of evacetrapib on Day 1 |
|
| Evacetrapib: Multiple Dose 12 Weeks | Experimental | Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks |
|
| Evacetrapib: Multiple Dose 24 Weeks | Experimental | Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks |
|
| Evacetrapib: Multiple Dose 52 Weeks | Experimental | Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) | Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose | |
| PK Parameters of Evacetrapib: Maximum Concentration (Cmax) | Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose | |
| PK Parameters of Evacetrapib: Terminal Half-life | Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose |
| Measure | Description | Time Frame |
|---|---|---|
| PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level | Day -1, Day 8 | |
| PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level | Day -1, Day 8 | |
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Inclusion Criteria:
Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:
Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening
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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States | ||
| Covance |
Participants were enrolled into 3 parallel cohorts. Each participant received a single dose, after which PK was evaluated for 7 days, and then continued receiving once daily doses for 12, 24, or 52 weeks. After the last once-daily dose, PK was again evaluated in each participant until the concentration of evacetrapib was too low to be measurable.
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| ID | Title | Description |
|---|---|---|
| FG000 | Evacetrapib: Multiple Dose 12 Weeks | 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12 consecutive weeks. |
| FG001 | Evacetrapib: Multiple Dose 24 Weeks | 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 24 consecutive weeks. |
| FG002 | Evacetrapib: Multiple Dose 52 Weeks | 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Evacetrapib: Multiple Dose 12 Weeks | 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks |
| BG001 | Evacetrapib: Multiple Dose 24 Weeks |
| 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) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) | All enrolled participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram∙hour/mililliter (ng∙h/mL) | Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose |
|
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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: Single Dose, All Participants | A single 130 mg oral dose of evacetrapib was administered on Day 1 to all participants. 130 mg of evacetrapib was administered orally once daily beginning on Day 8 for 12, 24, and 52 consecutive weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | 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 |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C568301 | evacetrapib |
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|
| PD Parameters of Evacetrapib: Total Cholesterol Level |
| Day -1, Day 8 |
| PD Parameters of Evacetrapib: Triglyceride Level | Day -1, Day 8 |
| Dallas |
| Texas |
| 75247 |
| United States |
| Covance Clinical Research Inc | Madison | Wisconsin | 53704 | United States |
| Physician Decision |
|
| Adverse Event |
|
| Death |
|
| Sponsor Decision |
|
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks
| BG002 | Evacetrapib: Multiple Dose 52 Weeks | 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Evacetrapib: Multiple Dose 12 Weeks |
130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks |
| OG002 | Evacetrapib: Multiple Dose 24 Weeks | 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks. |
| OG003 | Evacetrapib: Multiple Dose 52 Weeks | 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks. |
|
|
| Primary | PK Parameters of Evacetrapib: Maximum Concentration (Cmax) | All enrolled participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose |
|
|
|
| Primary | PK Parameters of Evacetrapib: Terminal Half-life | A single terminal half-life estimate was calculated from population PK estimates for apparent clearance and apparent volume of distribution across all participants, based on all available single dose data and multiple dose data. | Posted | Number | Days | Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose |
|
|
|
| Secondary | PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level | All enrolled participants in the single dose phase and had evaluable PD data. | Posted | Mean | Standard Deviation | millimole/Liter (mmol/L) | Day -1, Day 8 |
|
|
|
| Secondary | PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level | All enrolled participants who received at least 1 dose of study drug and had evaluable PD data. | Posted | Mean | Standard Deviation | mmol/L | Day -1, Day 8 |
|
|
|
| Secondary | PD Parameters of Evacetrapib: Total Cholesterol Level | All enrolled participants who received at least 1 dose of study drug and had evaluable PD data. | Posted | Mean | Standard Deviation | mmol | Day -1, Day 8 |
|
|
|
| Secondary | PD Parameters of Evacetrapib: Triglyceride Level | All enrolled participants who received at least 1 dose of study drug and had evaluable PD data. | Posted | Mean | Standard Deviation | mmol | Day -1, Day 8 |
|
|
|
| 0 |
| 101 |
| 12 |
| 101 |
| EG001 | Evacetrapib: Multiple Dose 12 Weeks | 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks. | 0 | 30 | 13 | 30 |
| EG002 | Evacetrapib: Multiple Dose 24 Weeks | 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks. | 0 | 32 | 17 | 32 |
| EG003 | Evacetrapib: Multiple Dose 52 Weeks | 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks. | 5 | 39 | 22 | 39 |
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Mycetoma mycotic | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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