Study of Food on Evacetrapib (LY2484595) in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

Effect of Food on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810432
• Other study ID #: 14626
• Secondary ID: I1V-MC-EIAX
• Status: Completed
• Phase: Phase 1
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: October 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.

This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy participants as determined by medical history and physical examination

• Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)

• Are able to eat a high fat breakfast and abide by the food restrictions throughout the study

Exclusion Criteria:

• Have known allergies to evacetrapib, related compounds or any components of the formulation

• 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

• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

• Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Evacetrapib
Administered orally

Other:
• High-fat Meal
Administered orally, at breakfast.

Locations

Country	Name	City	State
United States	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.	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib		Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Primary	PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCt) of Evacetrapib		Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Primary	PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib		Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose