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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02365558
Recruitment Status : Completed
First Posted : February 19, 2015
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Evacetrapib Drug: Omeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of the Impact of Increased Gastric pH Following Omeprazole Administration on the Pharmacokinetics of Evacetrapib in Healthy Subjects
Study Start Date : January 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Evacetrapib
Single oral dose of evacetrapib administered alone on Day 1 of Period 1.
Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Experimental: Omeprazole + 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.

Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Drug: Omeprazole
Administered orally




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib [ Time Frame: 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 ]
  2. Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib [ Time Frame: 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 ]
  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) [ Time Frame: 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365558


Locations
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United States, Wisconsin
Covance Madison
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02365558    
Other Study ID Numbers: 15373
I1V-MC-EIBO ( Other Identifier: Eli Lilly and Company )
First Posted: February 19, 2015    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Evacetrapib
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents