The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream

NCT ID: NCT01836198

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-11-30

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 study is split into two parts, Part A and Part B. Participants in Part A are divided into two cohorts (groups). Each cohort will participate in two study periods. Period 1 involves a single dose of LY2409021. Period 2 involves either gemfibrozil or ketoconazole given daily for 21 days with LY2409021 given once on Day 4. Part A will last for 51 days and will also involve screening within 27 days of the start of the study. Part B is only open to participants who successfully completed Part A of the study. Participants in Part B will receive clarithromycin given daily for 21 days with LY2409021 given once on Day 4. Part B will last for 29 days and will also involve screening within 27 days of the start of the study.

Detailed Description

Part B was added to the trial in August 2013, per protocol amendment.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

LY2409021 Only (Part A, Cohort 2)

Part A, Period 1. Participants will receive a single 20-mg oral dose of LY2409021 on Day 1.

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

LY2409021+Ketoconazole (Part A, Cohort 2)

Part 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 Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Ketoconazole

Intervention Type: DRUG

LY2409021+Clarithromycin (Part B)

Part 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.

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Clarithromycin

Intervention Type: DRUG

LY2409021 Only (Part A, Cohort 1)

Part A, Period 1. Participants will receive a single 20-milligram (mg) oral dose of LY2409021 on Day 1.

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

LY2409021+Gemfibrozil (Part A, Cohort 1)

Part 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 Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Gemfibrozil

Intervention Type: DRUG

Interventions

LY2409021

Intervention Type: DRUG

Gemfibrozil

Intervention Type: DRUG

Ketoconazole

Intervention Type: DRUG

Clarithromycin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United States

Other Identifiers

I1R-MC-GLBZ

Identifier Type: OTHER

Identifier Source: secondary_id

14586

Identifier Type: -

Identifier Source: org_study_id