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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIAQ | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine how much digoxin gets into the blood stream and how long it takes the body to get rid of it when given with the study drug evacetrapib. This study will also look at the effect of evacetrapib on the removal of digoxin from the body by the kidneys. Information about any side effects that may occur will be collected. This study will last approximately 33 days for each participant, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin | Active Comparator | 0.5 milligram (mg) digoxin administered orally once daily (QD) on Day 1 |
|
| Evacetrapib + Digoxin | Experimental | 130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evacetrapib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin | |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Clearance (CLr) of Digoxin | CLr was defined as the volume of serum cleared of digoxin per unit of time after a single dose of digoxin. | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin |
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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. | Dallas | Texas | 75247 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Evacetrapib+Digoxin | Period 1 (Day 1 through Day 6 predose): Participants received a single oral dose of 0.5 milligrams (mg) digoxin on Day 1 Period 2 (Day 6 postdose through Day 20): Participants received an oral dose of 130 mg evacetrapib once daily (QD) on Days 6 through 19 with single oral dose of 0.5 mg digoxin administered on Day 15 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Day 1 Through Day 6 Predose) |
|
| |||||||||||||||||||||
| Period 2 (Day 6 Postdose Through Day 20) |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Evacetrapib+Digoxin | Period 1 (Day 1 through Day 6 Predose): Participants received a single oral dose of 0.5 mg digoxin on Day 1 Period 2 (Day 6 Post-Dose through Day 20): Participants received an oral dose of 130 mg evacetrapib QD on Days 6 through 19 with a single oral dose of 0.5 mg digoxin administered on Day 15 |
| 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 Observed Drug Concentration (Cmax) of Digoxin | All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin |
|
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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 | Digoxin | Digoxin: Participants received a single dose of 0.5 mg digoxin administered orally on Day 1. Adverse events (AEs) are reported through predose on Day 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis | Infections and infestations | 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 |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin | Drug | Administered orally |
|
| United States |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| 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 |
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|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin | All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable AUC0-∞ data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin |
|
|
|
| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin | All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable tmax data. | Posted | Median | Full Range | hours | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin |
|
|
|
| Secondary | Renal Clearance (CLr) of Digoxin | CLr was defined as the volume of serum cleared of digoxin per unit of time after a single dose of digoxin. | All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable CLr data. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters/hour (L/h) | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin |
|
|
|
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Evacetrapib | Evacetrapib: Participants received 130 mg evacetrapib administered orally, alone, QD for Days 6 up to 15. AEs are reported from post-dose on Day 6 through predose of Digoxin on Day 15. | 0 | 15 | 1 | 15 |
| EG002 | Evacetrapib + Digoxin | Evacetrapib+Digoxin: Participants received 130 mg evacetrapib administered orally, QD for 14 days (Days 6 to 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15. AEs are reported from post-dose on Day 15 up to Day 33. | 0 | 15 | 1 | 15 |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |