Healthy
Conditions
Brief summary
The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.
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
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy participants of non-child bearing potential * Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2) * Must be willing to make oneself available for the whole study and be willing to follow study procedures
Exclusion criteria
* Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib | Predose on Day 1,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 |
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib | Predose on Day 1,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 |
Countries
Singapore
Participant flow
Pre-assignment details
Participants were randomized to 1 of 6 treatment sequences in a crossover design with 3 treatments; reference, test 1 and test 2. There was a washout period of ≥14 days between each dose. Participants were dosed 3 times during the entire study in periods 1, 2 and 3.
Participants by arm
| Arm | Count |
|---|---|
| Overall Participants Participants received a single dose of 130 mg evacetrapib tablet (a total of 3 doses of evacetrapib) given one time during each study period. | 95 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 2 (14 Days) | Sponsor Decision | 3 | 1 | 2 | 3 | 2 | 3 |
| Period 2 (14 Days) | Withdrawal by Subject | 1 | 0 | 1 | 0 | 0 | 0 |
| Period 3 (14 Days) | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 3 (14 Days) | Sponsor Decision | 0 | 0 | 0 | 0 | 1 | 0 |
| Period 3 (14 Days) | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall Participants |
|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 92 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 3 Participants |
| Region of Enrollment Singapore | 95 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 33 / 84 | 22 / 81 | 23 / 85 |
| serious Total, serious adverse events | 0 / 84 | 0 / 81 | 0 / 85 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
Time frame: Predose on Day 1,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
Population: All participants who received at least 1 dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib Reference (R) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib | 983 nangram/milliliter (ng/mL) | Geometric Coefficient of Variation 78 |
| Evacetrapib Test 1 (T1) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib | 1170 nangram/milliliter (ng/mL) | Geometric Coefficient of Variation 56 |
| Evacetrapib Test 2 (T2) | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib | 1120 nangram/milliliter (ng/mL) | Geometric Coefficient of Variation 66 |
Primary
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib
Time frame: Predose on Day 1,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
Population: All participants who received at least 1 dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib Reference (R) | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib | 14700 nanogram·hour/milliter (ng·h/mL) | Geometric Coefficient of Variation 53 |
| Evacetrapib Test 1 (T1) | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib | 16100 nanogram·hour/milliter (ng·h/mL) | Geometric Coefficient of Variation 45 |
| Evacetrapib Test 2 (T2) | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib | 15500 nanogram·hour/milliter (ng·h/mL) | Geometric Coefficient of Variation 49 |