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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Evacetrapib; Drug: Omeprazole

• Registration Number: NCT02365558
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-19
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2018-02
• Results First Submitted: 2018-02-18
• Results First Submitted QC: 2018-02-18
• Last Update Submitted: 2018-02-18
• Results First Posted: 2018-10-03
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evacetrapib	Evacetrapib	Single oral dose of evacetrapib administered alone on Day 1 of Period 1.
Omeprazole + Evacetrapib	Evacetrapib	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.
Omeprazole + Evacetrapib	Omeprazole	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib	Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib	Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])	Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose

Trial Locations

Locations (1)

Covance Madison; 🇺🇸 Madison, Wisconsin, United States