A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Evacetrapib; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02365558

I1V-MC-EIBO (Other Identifier)

15373

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

There are two parts to the study. Participation in both parts will be required.

The study will last approximately 30 days, not including screening.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy participants, as determined by medical history and physical examination
• Females must be of non-child-bearing potential
• Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

Exclusion criteria

• Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

34 participants in 2 patient groups

Evacetrapib

Experimental group

Description:

Single oral dose of evacetrapib administered alone on Day 1 of Period 1.

Treatment:

Drug: Evacetrapib

Omeprazole + Evacetrapib

Experimental group

Description:

In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20. Evacetrapib will be co-administered once, orally on Day 14.

Treatment:

Drug: Omeprazole

Drug: Evacetrapib