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A Study of Evacetrapib in Healthy Japanese Participants

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ClinicalTrials.gov Identifier: NCT02226653
Recruitment Status : Completed
First Posted : August 27, 2014
Results First Posted : October 10, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body. The study will also explore the effect of a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Bioequivalence and Food Effect Study of Evacetrapib Evaluating a Single Tablet Compared to Two Tablets in Healthy Japanese Subjects
Study Start Date : September 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Evacetrapib (reference)
Single oral dose of 1 tablet of evacetrapib on Day 1 of up to three of five periods
Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Experimental: Evacetrapib (test)
Single oral dose of 2 tablets of evacetrapib on Day 1 of up to three of five periods
Drug: Evacetrapib
Administered orally
Other Name: LY2484595




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted) [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4 ]
  2. PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted) [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4 ]

Secondary Outcome Measures :
  1. PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed) [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5 ]
  2. PK: AUC(0-∞)of Evacetrapib (Fasted and Fed) [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5 ]
  3. PK: Cmax of Evacetrapib (Fasted and Fed) [ Time Frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5 ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overtly healthy Japanese, as determined by medical history and physical examination
  • Have a body mass index (BMI) of 18.0 to 29.9 kg/m^2
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

  • 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
  • Have an abnormal supine blood pressure as determined by the investigator
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Are women who are pregnant or lactating
  • Have used or intend to use over-the-counter, prescription medications, or herbal medicine 14 days prior to enrollment and during the study
  • Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
  • Are participants who currently smoke more than 10 cigarettes per day or are unwilling to abide by smoking restrictions

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): NCT02226653


Locations
Japan
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.
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02226653     History of Changes
Other Study ID Numbers: 14627
I1V-JE-EIAY ( Other Identifier: Eli Lilly and Company )
First Posted: August 27, 2014    Key Record Dates
Results First Posted: October 10, 2018
Last Update Posted: November 8, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents