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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIAS | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal hepatic function. Information about any side effects that may occur will also be collected. This study will last approximately 28 days, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evacetrapib (Healthy) | Experimental | Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function |
|
| Evacetrapib (Hepatic, Mild) | Experimental | Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment |
|
| Evacetrapib (Hepatic, Moderate) | Experimental | Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment |
|
| Evacetrapib (Hepatic, Severe) | Experimental | Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib | tlast is defined as the last time point with a measurable concentration of Evacetrapib. | Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose |
| PK: Maximum Observed Concentration (Cmax) of Evacetrapib | Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose |
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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. | Miami | Florida | 33169 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Evacetrapib (Healthy) | Group 1: 130 milligrams (mg) evacetrapib administered once, orally as a tablet to participants with normal hepatic function |
| FG001 | Evacetrapib (Hepatic, Mild) | Group 2: 130 mg evacetrapib administered once, orally as a tablet to participants with mild hepatic impairment |
| FG002 | Evacetrapib (Hepatic, Moderate) | Group 3: 130 mg evacetrapib administered once, orally as a tablet to participants with moderate hepatic impairment |
| FG003 | Evacetrapib (Hepatic, Severe) | Group 4: 130 mg evacetrapib administered once, orally as a tablet to participants with severe hepatic impairment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Evacetrapib (Healthy) | Group 1: 130 milligrams (mg) evacetrapib administered once, orally as a tablet to participants with normal hepatic function |
| BG001 | Evacetrapib (Hepatic, Mild) |
| 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): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib | tlast is defined as the last time point with a measurable concentration of Evacetrapib. | Participants who received at least 1 dose of study drug and had evaluable PK (AUC0-tlast) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose |
|
Randomization to study completion (Up To 41 Days)
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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 (Healthy) | Group 1: 130 mg evacetrapib administered once, orally as a tablet to participants with normal hepatic function |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | 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 |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C568301 | evacetrapib |
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| United States |
| 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. | Orlando | Florida | 32806 | United States |
Group 2: 130 mg evacetrapib administered once, orally as a tablet to participants with mild hepatic impairment
| BG002 | Evacetrapib (Hepatic, Moderate) | Group 3: 130 mg evacetrapib administered once, orally as a tablet to participants with moderate hepatic impairment |
| BG003 | Evacetrapib (Hepatic, Severe) | Group 4: 130 mg evacetrapib administered once, orally as a tablet to participants with severe hepatic impairment |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
|
Group 2: 130 mg evacetrapib administered once, orally as a tablet to participants with mild hepatic impairment |
| OG002 | Evacetrapib (Hepatic, Moderate) | Group 3: 130 mg evacetrapib administered once, orally as a tablet to participants with moderate hepatic impairment |
| OG003 | Evacetrapib (Hepatic, Severe) | Group 4: 130 mg evacetrapib administered once, orally as a tablet to participants with severe hepatic impairment |
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of Evacetrapib | Participants who received at least 1 dose of study drug and had evaluable PK (Cmax) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose |
|
|
|
| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | Full Range | h | Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose |
|
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Evacetrapib (Hepatic, Mild) | Group 2: 130 mg evacetrapib administered once, orally as a tablet to participants with mild hepatic impairment | 0 | 8 | 4 | 8 |
| EG002 | Evacetrapib (Hepatic, Moderate) | Group 3: 130 mg evacetrapib administered once, orally, as a tablet to participants with moderate hepatic impairment | 0 | 8 | 3 | 8 |
| EG003 | Evacetrapib (Hepatic, Severe) | Group 4: 130 mg evacetrapib administered once, orally as a tablet to participants with severe hepatic impairment | 0 | 6 | 3 | 6 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | 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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| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Piloerection | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
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