A Study of Evacetrapib in Healthy Participants
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
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:
|
Gemfibrozil Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013