A Study of Different Particle Sizes of Evacetrapib in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Evacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02497391

I1V-MC-EIBA (Other Identifier)

14629

Details and patient eligibility

About

The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.

Enrollment: 95 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy participants of non-child bearing potential
• Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
• Must be willing to make oneself available for the whole study and be willing to follow study procedures

Exclusion criteria

• Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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95 participants in 3 patient groups

Evacetrapib Reference (R)

Experimental group

Description:

Single oral dose of 130 mg evacetrapib tablet given one time during one study period.

Treatment:

Drug: Evacetrapib

Evacetrapib Test 1 (T1)

Experimental group

Description:

Single oral dose of 130 mg evacetrapib tablet given one time during one study period.

Treatment:

Drug: Evacetrapib

Evacetrapib Test 2 (T2)

Experimental group

Description:

Single oral dose of 130 mg evacetrapib tablet given one time during one study period.

Treatment:

Drug: Evacetrapib