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Completed

NCT Number: NCT01836198

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary 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, Indiana, 47710, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2409021

Drug

Gemfibrozil

Drug

Ketoconazole

Drug

Clarithromycin

Drug

Primary outcomes

  1. Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021

    Time frame: Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only)

  2. Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021

    Time frame: Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effects of Potent Inhibition of CYP2C8, CYP2J2, and CYP3A4, Using Gemfibrozil, Ketoconazole, and Clarithromycin as Probes, on the Pharmacokinetics of LY2409021 in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2013
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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