Healthy Volunteers
Conditions
Brief summary
The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time. This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.
Interventions
DRUGEvacetrapib
Administered orally
DRUGPravastatin
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 * Have a body mass index of 18 to 32 kilograms per square meter (kg/m²) * Japanese participants must be first generation Japanese
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose |
| PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin | Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose |
Countries
United Kingdom
Participant flow
Pre-assignment details
All participants were administered 40 milligrams (mg) Pravastatin on Day 1 (Period 1) and 130 mg Evacetrapib on Days 2 through 11 and 40 mg Pravastatin coadministered on Day 11 (Period 2).
Participants by arm
| Arm | Count |
|---|---|
| Pravastatin and Evacetrapib + Pravastatin 40 mg oral dose of pravastatin was administered on Day 1. One hundred and thirty (130) mg oral dose of evacetrapib was administered QD on Days 2 through 11 and 40 mg oral dose of pravastatin was co-administered on Day 11. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Pravastatin and Evacetrapib + Pravastatin |
|---|---|
| Age, Continuous | 31.8 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 13 Participants |
| Region of Enrollment United Kingdom | 24 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 10 | 6 / 10 | 4 / 10 | 4 / 14 | 4 / 14 | 6 / 13 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 14 | 0 / 14 | 0 / 13 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin
Time frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
Population: All participants who had evaluable Cmax results at the specific time points.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pravastatin (Period 1) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin | 142 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 31 |
| Evacetrapib + Pravastatin (Period 2) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin | 128 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin
Time frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
Population: All participants who had evaluable AUC(0-∞) at the specific time points.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Pravastatin (Period 1) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin | 257 nanograms*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 27 |
| Evacetrapib + Pravastatin (Period 2) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin | 229 nanograms*hours/milliliters (ng*h/mL) | Geometric Coefficient of Variation 37 |
Primary
PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin
Time frame: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
Population: All enrolled participants with evaluable tmax results at the specific time points.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pravastatin (Period 1) | PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin | 1.00 hours |
| Evacetrapib + Pravastatin (Period 2) | PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin | 0.75 hours |