Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected. There are two parts to the study. Participation in both parts will be required. The study will last approximately 30 days, not including screening.
Interventions
DRUGEvacetrapib
Administered orally
DRUGOmeprazole
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy participants, as determined by medical history and physical examination * Females must be of non-child-bearing potential * Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)
Exclusion criteria
* Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib | Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose |
| Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib | Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) | Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Single oral dose of 130 mg evacetrapib on Day 1 and oral doses of 40 mg omeprazole QD on Days 8 through 20, with a single oral dose of 130 mg evacetrapib coadministered on Day 14 | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (Day 1 Through Day 7) | Adverse Event | 1 | 0 |
| Period 2 (Day 8 Through Day 20) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 40.9 Years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 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 | 19 Participants |
| Region of Enrollment United States | 34 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 30 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 | 5 / 34 | 2 / 33 | 3 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 | 0 / 33 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
Time frame: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) | 12400 nanogram*hour per milliliter (ng·h/mL) | Geometric Coefficient of Variation 52 |
| Evacetrapib + Omeprazole | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) | 14100 nanogram*hour per milliliter (ng·h/mL) | Geometric Coefficient of Variation 66 |
Primary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
Time frame: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib | 748 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 79 |
| Evacetrapib + Omeprazole | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib | 959 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 88 |
Primary
Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib
Time frame: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Evacetrapib | Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib | 3.00 Hours |
| Evacetrapib + Omeprazole | Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib | 3.00 Hours |