A Study of Evacetrapib in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01736254
First received: November 26, 2012
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to measure how much of the study drug (evacetrapib) gets into the blood stream and how long it takes the body to get rid of it when given with gemfibrozil. Each participant will receive gemfibrozil alone, evacetrapib alone, and both drugs in combination. There is no washout period between doses. The safety of both of the study drugs given together will be evaluated. Information about any side effects that may occur will also be collected. This study will last approximately 36 days.


Condition Intervention Phase
Healthy Volunteers
Drug: Evacetrapib
Drug: Gemfibrozil
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Gemfibrozil on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib [ Time Frame: Predose up to 24 hours Post-dose Day 11 and Day 22 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Evacetrapib [ Time Frame: Predose up to 24 hours Post-dose Day 11 and Day 22 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib [ Time Frame: Predose up to 24 hours Post-dose Day 11 and Day 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK): Area Under the Concentration Curve Over a 12 Hour Dosing Interval (AUCτ) of Gemfibrozil [ Time Frame: Predose up to 12 hours Post-dose Day 1 and Day 13 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Gemfibrozil [ Time Frame: Predose up to 12 hours Post-dose Day 1 and Day 13 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Gemfibrozil [ Time Frame: Predose up to 12 hours Post-dose Day 1 and Day 13 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemfibrozil
Single oral dose of 600 milligrams (mg) gemfibrozil on Day 1
Drug: Evacetrapib
Oral administration
Other Name: LY2484595
Experimental: Evacetrapib
Oral doses of 130 mg of evacetrapib once a day (QD) for 10 days (Day 2 through Day 12)
Drug: Gemfibrozil
Oral administration
Experimental: Evacetrapib + Gemfibrozil
Oral doses of 600 mg gemfibrozil twice a day (BID) and 130 mg evacetrapib once a day (QD) for 10 days (Day 13 through Day 22). Single oral dose of 600 mg gemfibrozil on Day 23.
Drug: Evacetrapib
Oral administration
Other Name: LY2484595
Drug: Gemfibrozil
Oral administration

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participants as determined by medical history and physical examination
  • Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

Exclusion Criteria:

  • Have known allergies to evacetrapib and gemfibrozil, related compounds or any components of the formulation
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Currently smoke cigarettes or use tobacco or nicotine substitutes
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736254

Locations
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01736254     History of Changes
Other Study ID Numbers: 14701, I1V-MC-EIBD
Study First Received: November 26, 2012
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Evacetrapib
Gemfibrozil
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014