Effect of Food on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
Study Overview
Brief Summary
The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.
The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.
This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- 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
- •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)
- •Are able to eat a high fat breakfast and abide by the food restrictions throughout the study
Exclusion Criteria
- •Have known allergies to evacetrapib, related compounds or any components of the formulation
- •Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- •Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes
Arms & Interventions
Evacetrapib (Fasted)
130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.
Intervention: Evacetrapib (Drug)
Evacetrapib (Fed)
130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.
Intervention: Evacetrapib (Drug)
Evacetrapib (Fed)
130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.
Intervention: High-fat Meal (Other)
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
Time Frame: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib
Time Frame: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
Time Frame: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Secondary Outcomes
No secondary outcomes reported