A Study of Different Particle Sizes of Evacetrapib in Healthy Participants
- Registration Number
- NCT02497391
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- Overtly healthy participants of non-child bearing potential
- Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
- Must be willing to make oneself available for the whole study and be willing to follow study procedures
- Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Evacetrapib Reference (R) Evacetrapib Single oral dose of 130 mg evacetrapib tablet given one time during one study period. Evacetrapib Test 1 (T1) Evacetrapib Single oral dose of 130 mg evacetrapib tablet given one time during one study period. Evacetrapib Test 2 (T2) Evacetrapib Single oral dose of 130 mg evacetrapib tablet given one time during one study period.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 Hours Postdose PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 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.
🇸🇬Singapore, Singapore