Status:
COMPLETED
A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02271425
Start Date
October 1 2014
End Date
November 1 2014
Last Update
March 1 2019
Active Locations (1)
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1
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