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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIAW | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time.
This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pravastatin | Experimental | Single 40 milligram (mg) oral dose of pravastatin administered on Day 1. |
|
| Evacetrapib + Pravastatin | Experimental | Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose | |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose | |
| PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose |
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Inclusion 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. | Leeds | West Yorkshire | LS2 9LH |
All participants were administered 40 milligrams (mg) Pravastatin on Day 1 (Period 1) and 130 mg Evacetrapib on Days 2 through 11 and 40 mg Pravastatin coadministered on Day 11 (Period 2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pravastatin | 40 mg oral dose of pravastatin was administered on Day 1. |
| FG001 | Evacetrapib + Pravastatin | 130 mg oral dose of evacetrapib was administered once daily (QD) on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pravastatin and Evacetrapib + Pravastatin | 40 mg oral dose of pravastatin was administered on Day 1. One hundred and thirty (130) mg oral dose of evacetrapib was administered QD on Days 2 through 11 and 40 mg oral dose of pravastatin was co-administered on Day 11. |
| 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 Pravastatin | All participants who had evaluable Cmax results at the specific time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 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 | 40 mg Pravastatin Japanese | 40 mg oral dose of pravastatin was administered on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | 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 |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Pravastatin | Drug | Administered orally |
|
| United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin | All participants who had evaluable AUC(0-∞) at the specific time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliters (ng*h/mL) | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose |
|
|
|
| Primary | PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin | All enrolled participants with evaluable tmax results at the specific time points. | Posted | Median | Full Range | hours | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose |
|
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | 130 mg Evacetrapib Japanese | 130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11. | 0 | 10 | 6 | 10 |
| EG002 | 40 mg Pravastatin + 130 mg Evacetrapib Japanese | 40 mg oral dose of pravastatin was administered on Day 1. 130 mg oral dose of evacetrapib was administered QD on Days 2 through11 and a 40 mg oral dose of pravastatin coadministered on Day 11. | 0 | 10 | 4 | 10 |
| EG003 | 40 mg Pravastatin Non-Japanese | 40 mg oral dose of pravastatin was administered on Day 1. | 0 | 14 | 4 | 14 |
| EG004 | 130 mg Evacetrapib Non-Japanese | 130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11. | 0 | 14 | 4 | 14 |
| EG005 | 40 mg Pravastatin + 130-mg Evacetrapib Non-Japanese | 40 mg oral dose of pravastatin was administered on Day 1. 130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11. | 0 | 13 | 6 | 13 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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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.
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |