Completed
Effects of Potent Inhibition of CYP2C8, CYP2J2, and CYP3A4, Using Gemfibrozil, Ketoconazole, and Clarithromycin as Probes, on the Pharmacokinetics of LY2409021 in Healthy Subjects
What is being tested
LY2409021
+ LY2409021
+ Gemfibrozil
Drug
Who is being recruted
From 18 to 65 Years
+8 Eligibility Criteria
How is the trial designed
Basic Science Study
Phase 1
Interventional
Study Start: May 2013
Summary
Principal SponsorEli Lilly and Company
Last updated: March 8, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.Part B was added to the trial in August 2013, per protocol amendment.
Principal SponsorEli Lilly and Company
Last updated: March 8, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
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])
5 exclusion criteria prevent from participating
Participants that have a contraindication to use of clarithromycin
Participants that have a personal or family history of long QT syndrome
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
Participants with a family history of sudden unexplained death or cardiac death in an immediate family member under 60 years of age
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
5 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPart A, Period 1. Participants will receive a single 20-milligram (mg) oral dose of LY2409021 on Day 1.
Group II
ExperimentalPart A, Period 2. Participants will receive a morning (AM) and evening (PM) oral dose of 600 mg gemfibrozil on Days 1-20 and an AM oral dose only of 600 mg gemfibrozil on Day 21.
Participants will also receive a single 20-mg oral dose of LY2409021 on Day 4.
Group III
ExperimentalPart A, Period 1. Participants will receive a single 20-mg oral dose of LY2409021 on Day 1.
Group IV
ExperimentalPart A, Period 2. Participants will receive a once-daily 400-mg oral dose of ketoconazole on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.
Group 5
ExperimentalPart B. Participants will receive a twice-daily 500-mg oral dose of clarithromycin on Days 1-21 and a single 20-mg oral dose of LY2409021 on Day 4.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
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, United StatesOpen 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. in Google MapsCompletedOne Study Center