Effect of Rifampin on the Pharmacokinetics of Evacetrapib in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Evacetrapib
Period 1:
130 milligram (mg) evacetrapib administered orally, once on Day 1
Intervention: Evacetrapib (Drug)
Evacetrapib + Rifampin
Period 2:
Rifampin: 600 mg administered orally, once daily (QD) for 14 days (Days 9 to 22)
Evacetrapib: 130 mg administered orally once on Day 16
Intervention: Evacetrapib (Drug)
Evacetrapib + Rifampin
Period 2:
Rifampin: 600 mg administered orally, once daily (QD) for 14 days (Days 9 to 22)
Evacetrapib: 130 mg administered orally once on Day 16
Intervention: Rifampin (Drug)
Outcomes
Primary Outcomes
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
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
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
Secondary Outcomes
No secondary outcomes reported