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A Study of Different Particle Sizes of Evacetrapib in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02497391
Recruitment Status : Completed
First Posted : July 14, 2015
Results First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Evacetrapib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Bioequivalence Study in Healthy Subjects Administered Evacetrapib Tablets of Varying Particle Sizes
Study Start Date : July 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Evacetrapib Reference (R)
Single oral dose of 130 mg evacetrapib tablet given one time during one study period.
 Drug: Evacetrapib
administered orally
Other Name: LY2484595
Experimental: Evacetrapib Test 1 (T1)
Single oral dose of 130 mg evacetrapib tablet given one time during one study period.
 Drug: Evacetrapib
administered orally
Other Name: LY2484595
Experimental: Evacetrapib Test 2 (T2)
Single oral dose of 130 mg evacetrapib tablet given one time during one study period.
 Drug: Evacetrapib
administered orally
Other Name: LY2484595


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib [ Time Frame: 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 ]
  2. PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib [ Time Frame: 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 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.
Contacts and Locations
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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): NCT02497391


Locations
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Singapore
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, 117597
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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02497391    
Other Study ID Numbers: 14629
I1V-MC-EIBA ( Other Identifier: Eli Lilly and Company )
First Posted: July 14, 2015    Key Record Dates
Results First Posted: December 3, 2018
Last Update Posted: December 3, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents