- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01810432
Study of Food on Evacetrapib (LY2484595) in Healthy Participants
Effect of Food on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Florida
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Daytona Beach, Florida, United States, 32117
- 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.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Evacetrapib (Fasted)
130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.
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Administered orally
Other Names:
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Experimental: Evacetrapib (Fed)
130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.
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Administered orally
Other Names:
Administered orally, at breakfast.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
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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
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Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
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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
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Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14626
- I1V-MC-EIAX (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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