A Study of Evacetrapib and Rifampin in Healthy Participants
- Registration Number
- NCT01908582
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evacetrapib + Rifampin Evacetrapib 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 Evacetrapib + Rifampin 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 Evacetrapib Evacetrapib Period 1: 130 milligram (mg) evacetrapib administered orally, once on Day 1
- Primary Outcome Measures
Name Time Method 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 (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, 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇺🇸Madison, Wisconsin, United States