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Study of Food on Evacetrapib (LY2484595) in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01810432
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Evacetrapib Other: High-fat Meal Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: Evacetrapib (Fasted)
130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.
Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Experimental: Evacetrapib (Fed)
130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.
Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Other: High-fat Meal
Administered orally, at breakfast.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01810432    
Other Study ID Numbers: 14626
I1V-MC-EIAX ( Other Identifier: Eli Lilly and Company )
First Posted: March 13, 2013    Key Record Dates
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents