Cardiovascular Disease
Conditions
Brief summary
The purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment compared to participants with normal renal (kidney) function. This study will last approximately 8 weeks.
Interventions
DRUGEvacetrapib
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Female participants are not of child-bearing potential * Have a body mass index of 18 to 40 kilograms per square meter (kg/m\^2) * Participants with normal renal function - healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function (assessed by estimated creatinine clearance \[CLcr\] greater than or equal to 90 milliliters per minute \[mL/min\] at screening) * Participants with severe renal impairment - estimated CLcr less than 30 mL/min at screening and are not undergoing hemodialysis
Exclusion criteria
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data * Participants who are unwilling to comply with the dietary requirements/restrictions during the study * Hemoglobin less than 9 grams/deciliter (g/dL) or significant active hematological disease from causes other than underlying renal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Time Zero To Time Tlast, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Evacetrapib (Participants With Renal Impairment) Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment. | 10 |
| Evacetrapib (Healthy Participants) Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Evacetrapib (Participants With Renal Impairment) | Total | Evacetrapib (Healthy Participants) |
|---|---|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 9.6 | 63.4 years STANDARD_DEVIATION 8.8 | 61.5 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 11 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 9 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 15 Participants | 9 Participants |
| Region of Enrollment United States | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 10 | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose
Population: All participants who received evacetrapib and had evaluable AUC(0-∞) data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib (Participants With Renal Impairment) | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib | 15500 ng*h/mL | Geometric Coefficient of Variation 50 |
| Evacetrapib (Healthy Participants) | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib | 16300 ng*h/mL | Geometric Coefficient of Variation 39 |
Primary
Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Time Zero To Time Tlast, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose
Population: All participants who received evacetrapib and had evaluable AUC(0-Tlast) data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib (Participants With Renal Impairment) | Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Time Zero To Time Tlast, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib | 15200 nanograms*hours/milliliter (ng*h/mL) | Geometric Coefficient of Variation 49 |
| Evacetrapib (Healthy Participants) | Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Time Zero To Time Tlast, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib | 16000 nanograms*hours/milliliter (ng*h/mL) | Geometric Coefficient of Variation 37 |
Secondary
Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose
Population: All participants who received evacetrapib and had evaluable Cmax data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib (Participants With Renal Impairment) | Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib | 969 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
| Evacetrapib (Healthy Participants) | Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib | 1140 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 44 |