Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to measure and compare the amounts of the study drug evacetrapib found in the blood after taking two different formulations. The study has 3 periods. Participants will take each formulation by mouth at least once. A minimum of 14 days will pass between study drug doses. The safety and tolerability of the study drug will also be examined. Information about any side effects that may occur will also be collected. This study will last approximately 6 weeks.
Interventions
DRUGEvacetrapib
Administered orally
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
* Male participants who agree to use a reliable method of birth control and not donate sperm during the study and for 90 days after study completion * Female participants who are not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause * Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2) * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion criteria
* Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product * Have known allergies to evacetrapib, related compounds or any components of the formulation, or history of significant allergic disease as determined by the investigator * Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders * Regularly use known drugs of abuse and/or show positive findings on urinary drug screening * Are women who are pregnant or lactating * Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during the study * Have donated blood of more than 500 milliliters (mL) within the last month * Have an average weekly alcohol intake that exceeds 21 units per week (for males) and 14 units per week (for females) or are unwilling to stop alcohol consumption 48 hours prior to each dose and while resident at the Clinical Research Unit (CRU) * Currently smoke or use tobacco or nicotine products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595) | Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period | The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test). |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595) | Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period | Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC\[0-∞\]) is summarized for each solid fraction control (Reference and Test). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 130 mg Evacetrapib Participants randomized to receive a single dose of 130 mg evacetrapib of either of the two different solid fraction controls on Day 1 of each of 3 treatment periods, according to their assigned treatment sequence. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout Period 1 (at Least 14 Days) | Adverse Event | 1 | 0 |
| Washout Period 1 (at Least 14 Days) | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | 130 mg Evacetrapib |
|---|---|
| Age, Continuous | 41.6 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 58 | 1 / 59 |
| serious Total, serious adverse events | 0 / 58 | 0 / 59 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595)
Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC\[0-∞\]) is summarized for each solid fraction control (Reference and Test).
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period
Population: Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Reference | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595) | 10400 nanograms times hours per milliliter | Geometric Coefficient of Variation 56 |
| Test | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595) | 10300 nanograms times hours per milliliter | Geometric Coefficient of Variation 68 |
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595)
The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test).
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period
Population: Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Reference | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595) | 604 nanograms per milliliter | Geometric Coefficient of Variation 76 |
| Test | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595) | 597 nanograms per milliliter | Geometric Coefficient of Variation 102 |