Clinical trial NCT02271425: A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants
Official title: An Absolute Bioavailability Study of Evacetrapib in Healthy Subjects Using the Intravenous Tracer Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-10-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics (PK): Dose Normalized Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: 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.
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: