A Study of Evacetrapib in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Evacetrapib; Drug: Gemfibrozil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736254

14701

I1V-MC-EIBD (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether concentrations of the study drug (evacetrapib) in the blood stream is the same or is different when the person is also taking gemfibrozil (a drug used to lower lipid levels). Each participant will receive gemfibrozil alone, evacetrapib alone, and both drugs in combination. There is no washout period between doses. The safety of both of the study drugs given together will be evaluated. Information about any side effects that may have occurred will also be collected. This study will last approximately 36 days.

Enrollment: 24 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/m^2)

Exclusion criteria

• Have known allergies to evacetrapib and gemfibrozil, 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
• Currently smoke cigarettes or use tobacco or nicotine substitutes

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Gemfibrozil

Experimental group

Description:

Single oral dose of 600 milligrams (mg) gemfibrozil on Day 1

Treatment:

Drug: Gemfibrozil

Evacetrapib

Experimental group

Description:

Oral doses of 130 mg evacetrapib once a day (QD) for 10 days (Day 2 through Day 12)

Treatment:

Drug: Evacetrapib

Evacetrapib + Gemfibrozil

Experimental group

Description:

Oral doses of 600 mg gemfibrozil twice a day (BID) and 130 mg evacetrapib QD for 10 days (Day 13 through Day 22). Single oral dose of 600 mg gemfibrozil on Day 23.

Treatment:

Drug: Gemfibrozil

Drug: Evacetrapib