A Study of Evacetrapib in Japanese and Non-Japanese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Evacetrapib; Drug: Pravastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01958489

14625

I1V-MC-EIAW (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time.

This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Overtly 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)
• Japanese participants must be first generation Japanese

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 2 patient groups

Pravastatin

Experimental group

Description:

Single 40 milligram (mg) oral dose of pravastatin administered on Day 1.

Treatment:

Drug: Pravastatin

Evacetrapib + Pravastatin

Experimental group

Description:

Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.

Treatment:

Drug: Pravastatin

Drug: Evacetrapib