Status:
COMPLETED
A Study of Evacetrapib in Healthy Japanese Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy Volunteers
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02226653
Start Date
September 1 2014
End Date
April 1 2015
Last Update
November 8 2018
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.
Fukuoka, Japan, 812-0025