Status:
COMPLETED
The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes to get rid of it. The ...
Detailed Description
Part B was added to the trial in August 2013, per protocol amendment.
Eligibility Criteria
Inclusion
- Participants are overtly healthy males or females, as determined by medical history and physical examination
- Participants have a body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m\^2), inclusive, at screening
- Participants have a fasting blood glucose of 54 to 110 milligrams per deciliter (mg/dL) (3.0 to 6.1 micromoles per liter \[mmol/L\])
Exclusion
- Participants that have a contraindication to use of clarithromycin
- Participants that have a personal or family history of long QT syndrome
- Participants with a family history of sudden unexplained death or cardiac death in an immediate family member under 60 years of age
- Participants with a personal history of unexplained syncope within the last year
- Participants who have taken drugs or substances known to be an inducer or inhibitor of cytochrome P450 (CYP)3A4 or CYP2C8 or CYP2J2 (for example, St. John's wort, rifampin, ketoconazole, trimethoprim) within 30 days prior to the first dose
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01836198
Start Date
May 1 2013
End Date
November 1 2013
Last Update
March 8 2019
Active Locations (1)
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1
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.
Evansville, Indiana, United States, 47710