Healthy Volunteers
Conditions
Brief summary
The 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 to healthy participants. Information about any side effects that may occur will also be collected. The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period. This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.
Interventions
DRUGEvacetrapib
Administered orally
OTHERHigh-fat Meal
Administered orally, at breakfast.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants as determined by medical history and physical examination * Have a body mass index of 18 to 32 kilograms per square meter (kg/m²) * Are able to eat a high fat breakfast and abide by the food restrictions throughout the study
Exclusion criteria
* Have known allergies to evacetrapib, related compounds or any components of the formulation * Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study * Regularly use known drugs of abuse and/or show positive findings on urinary drug screening * Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Evacetrapib Sequence 1-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) in a fasted state. Following a 14-day washout period, participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast.
Sequence 2-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 | Lost to Follow-up | 1 | 1 |
| Period 2 | Physician Decision | 1 | 0 |
| Period 2 | Withdrawal by Subject | 2 | 1 |
| Washout | Adverse Event | 1 | 0 |
| Washout | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Evacetrapib |
|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 39 | 4 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
Time frame: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Population: All participants with evaluable Cmax data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib (Fasted) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | 1140 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 73 |
| Evacetrapib (Fed) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | 1720 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 22 |
Primary
PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib
Time frame: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Population: All participants with evaluable AUCτ data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib (Fasted) | PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib | 9930 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 49 |
| Evacetrapib (Fed) | PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib | 14400 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 19 |
Primary
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
Time frame: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Population: All participants with evaluable tmax data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Evacetrapib (Fasted) | PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | 3.00 hours (h) |
| Evacetrapib (Fed) | PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | 3.00 hours (h) |