Healthy Volunteers
Conditions
Brief summary
The main purpose of this study is to determine how much evacetrapib gets into the blood stream and how long it takes the body to get rid of it when given with rifampin. The safety and tolerability of the two drugs, given together, will also be evaluated. The study will also look at blood cholesterol levels and levels of a hormone called cortisol before and after taking rifampin. Information about any side effects that may occur will also be collected. For each participant, this study will include 2 periods in fixed order. The study will last approximately 29 days.
Interventions
DRUGEvacetrapib
Administered orally
DRUGRifampin
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 males and females (of non child-bearing potential) * Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2), inclusive, at screening
Exclusion criteria
* Have known allergies to evacetrapib, rifampin, related compounds or any components of either formulation, or history of significant allergic disease as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
| Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |
| Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib | Day 1 and Day 16, predose of evacetrapib and 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 |
|---|---|
| All Participants Period 1:
Evacetrapib 130 mg administered orally as a single dose on Day 1
Period 2:
Rifampin 600 mg administered orally QD of Days 9 to 22 Evacetrapib 130 mg administered orally as a single dose on Day 16 | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Period 2 | Physician Decision | 1 |
| Period 2 | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 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 | 15 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 20 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 | 3 / 26 | 26 / 26 | 5 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 26 |
Outcome results
Primary
Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib
Time frame: Day 1 and Day 16, predose of evacetrapib and 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 1 dose of evacetrapib and have evaluable evacetrapib concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib | Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib | 9810 nanograms * hours per milliliter | Geometric Coefficient of Variation 47 |
| Evacetrapib + Rifampin | Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib | 2070 nanograms * hours per milliliter | Geometric Coefficient of Variation 42 |
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
Time frame: Day 1 and Day 16, predose of evacetrapib and 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 1 dose of rifampin or evacetrapib and had evaluable evacetrapib concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Evacetrapib | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | 599 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 64 |
| Evacetrapib + Rifampin | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib | 269 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 55 |
Primary
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
Time frame: Day 1 and Day 16, predose of evacetrapib and 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 1 dose of rifampin or evacetrapib and had evaluable evacetrapib concentration data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Evacetrapib | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | 2.00 hours |
| Evacetrapib + Rifampin | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | 2.00 hours |