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A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02271425
Recruitment Status : Completed
First Posted : October 22, 2014
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

Evacetrapib (study drug) is an investigational drug being developed with the aim to help people at high risk of heart problems in the future.

In this study we will be comparing how much of the study drug gets into the blood stream when it is given as a single dose (in tablet form) compared to an intravenous injection (given directly into a vein via a small needle).

The study is expected to last at least 15 days for each participant, not including screening. Screening will occur up to 28 days before the study drug is given.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Absolute Bioavailability Study of Evacetrapib in Healthy Subjects Using the Intravenous Tracer Method
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Evacetrapib Tablet + Evacetrapib Intravenous
A single oral dose of 130 milligrams (mg) evacetrapib tablet + a single intravenous (IV) dose of 175 micrograms (μg)[¹³C₈] evacetrapib administered over a 4 hour infusion.
 Drug: Evacetrapib Tablet
Oral administration
Other Name: LY2484595

Drug: Evacetrapib Intravenous
Intravenous administration
Other Name: LY2484595


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Dose Normalized Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib [ Time Frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.25, 4.5, 5, 5.5, 6, 6.5, 8, 10, 12, Day 2; 24, 36 Day 3; 48 Day 4; 72 Day 5; 96 Day 6; 120 Day 7; 144 and Day 8; 168 hours post-dose ]

Eligibility Criteria
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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:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Female participants are post menopausal women or women not of child bearing potential due to surgical sterilization (at least 6 weeks after surgical hysterectomy, bilateral oophorectomy, or tubal occlusion) confirmed by medical history, or menopause
  • Have a body mass index (BMI) of less than 32 kilograms per square meter (kg/m^2)
  • Have given written informed consent approved by Eli Lilly and Company and the ethical review board (ERB) governing the site

Exclusion Criteria:

  • Have known allergies to evacetrapib, related compounds or any components of the formulation, intolerance to alcohol containing products, or history of significant allergic disease as determined by the investigator
  • Have an abnormal 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
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Are women who are pregnant or are lactating
  • Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements/herbal medicine) 14 days prior to the first dose and during the study. The use of topical medicine, provided there is no evidence of chronic dosing with risk of systemic exposure, and occasional acetaminophen is acceptable
  • Have donated blood of more than 500 milliliter (mL) within the last 3 months

  • Are unwilling to comply with the dietary requirements/restrictions during the study:

    • Consume only the meals provided during the inpatient appointments,
    • Refrain from eating any food or drinking any beverages containing grapefruit, grapefruit juice, Seville oranges, Seville orange juice, star fruit, pomelo, or commercial apple juice or orange juice for at least 7 days prior to the first dose
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): NCT02271425


Locations
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United Kingdom
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.
Leeds, West Yorkshire, United Kingdom, LS2 9LH
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: NCT02271425    
Other Study ID Numbers: 14622
I1V-MC-EIAT ( Other Identifier: Eli Lilly and Company )
First Posted: October 22, 2014    Key Record Dates
Results First Posted: March 1, 2019
Last Update Posted: March 1, 2019
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