No longer a GSK study

Study Description:

This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Ondansetron, also known as Zofran, is a marketed compound used for the prevention of nausea and vomiting. This study, called a thorough QT study, will characterize the effects of a single intravenous (IV) dose of ondansetron on cardiac repolarization as compared to placebo. Moxifloxacin, a commercially available antibiotic known to cause a mild QT prolongation, will be used as a positive control and will be given orally. The cardiac repolarization will be measured by taking consecutive ECGs on a recording device known as a Holter monitor and measuring the QT interval at specified times. In addition, blood samples will also be taken at specified times and will be used to measure the amount of study medication in the body.

GSK Study ID:

115458


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT01449188


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Nausea and/or Vomiting

Product

ondansetron

Collaborators

N/A


Date

August 2011 to December 2011

Type

Interventional

Phase

1


Gender

All

Age

18 years - 45 years

Accepts Healthy Volunteers

Yes


This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

United States, Texas, Austin 78744Completed

Study Design

  • Primary Purpose: Other
  • Allocation: Randomized
  • Study Design: Crossover Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Yes
  • Masked Caregiver: No
  • Masked Investigator: Yes
  • Masked Assessor: No
Primary Outcomes:

  • Change in QTcF after a single dose of Ondansetron given IV over 15 minutes.
    Timeframe: Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject’s participation in the study, from screening through follow-up will be an average of 11 weeks.

Secondary Outcomes:

  • characterize relationship between changes in ddQTc and plasma concentrations of ondansetron
    Timeframe: Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject’s participation in the study, from screening through follow-up will be an average of 11 weeks.

  • characterize relationship between QT interval and plasma ondansetron
    Timeframe: Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject’s participation in the study, from screening through follow-up will be an average of 11 weeks.

  • characterize the effect on QTcI and QTcB relative to placebo between the two doses of ondansetron and moxifloxacin
    Timeframe: Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject’s participation in the study, from screening through follow-up will be an average of 11 weeks.

  • characterize effect on QT and HR relative to placebo of the two doses of ondansetron and moxifloxacin.
    Timeframe: Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject’s participation in the study, from screening through follow-up will be an average of 11 weeks.

  • characterize the pharmacokinetics of ondansetron.
    Timeframe: Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject’s participation in the study, from screening through follow-up will be an average of 11 weeks.

  • characterize safety and tolerability of the two doses of ondansetron.
    Timeframe: Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject’s participation in the study, from screening through follow-up will be an average of 11 weeks.

  • characterize the pharmacokinetics of moxifloxacin if needed.
    Timeframe: Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject’s participation in the study, from screening through follow-up will be an average of 11 weeks.

Arms:
  • 4

Interventions:

  • Drug: ondansetron
  • Drug: moxifloxacin
  • Other: saline

Keyword:

  • ondansetron, moxifloxacin, Zofran, thorough QT study, IV
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 60

Clinical Publications:

  • Peiying Zuo, Lynda J Haberer, Lei Fang, Thomas Hunt, Derry Ridgeway, Mark W Russo.Integration of Modeling and Simulation with Ondansetron Thorough QTc Data to Support Labeling Changes.J Clin Pharmacol.2014;54(11):1221-1229