Study of Food on Evacetrapib (LY2484595) in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT01810432|
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Evacetrapib Other: High-fat Meal||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Food on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Evacetrapib (Fasted)
130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.
Other Name: LY2484595
Experimental: Evacetrapib (Fed)
130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.
Other Name: LY2484595
Other: High-fat Meal
Administered orally, at breakfast.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810432
|United States, Florida|
|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.|
|Daytona Beach, Florida, United States, 32117|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|