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

NCT02365558 | Completed Phase 1 Results

• 2 other identifiers: 15373I1V-MC-EIBO
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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): 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): 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

Study Arms (2)

Evacetrapib

EXPERIMENTAL

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

Drug: Evacetrapib

Omeprazole + Evacetrapib

EXPERIMENTAL

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.

Drug: Evacetrapib; Drug: Omeprazole

Interventions

Evacetrapib DRUG

Administered orally

Also known as: LY2484595

Evacetrapib; Omeprazole + Evacetrapib

Omeprazole DRUG

Administered orally

Omeprazole + Evacetrapib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Madison

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

evacetrapib; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 19, 2015
• Study Start: January 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 3, 2018
• Results First Posted: October 3, 2018

Record last verified: 2018-02

Locations

US (1)