Study of Food on Evacetrapib (LY2484595) in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Evacetrapib; Other: High-fat Meal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01810432

I1V-MC-EIAX (Other Identifier)

14626

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Evacetrapib (Fasted)

Experimental group

Description:

130 milligram (mg) oral dose of evacetrapib once daily in a fasted state for 10 days.

Treatment:

Drug: Evacetrapib

Evacetrapib (Fed)

Experimental group

Description:

130 mg oral dose of evacetrapib once daily following a high-fat breakfast for 10 days.

Treatment:

Drug: Evacetrapib

Other: High-fat Meal