Study of Food on Evacetrapib (LY2484595) in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Evacetrapib; Other: High-fat Meal

• Registration Number: NCT01810432
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2018-02-18
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-10
• Last Update Submitted: 2018-10-10
• Results First Posted: 2018-10-12
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Evacetrapib (Fed)	High-fat Meal	130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.
Evacetrapib (Fasted)	Evacetrapib	130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.
Evacetrapib (Fed)	Evacetrapib	130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.

Primary Outcome Measures

Name	Time	Method
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
PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib	Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
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

Trial Locations

Locations (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.; 🇺🇸 Daytona Beach, Florida, United States