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Trial record 3 of 4 for:    newton-cheh

Genetics of QT Response to Moxifloxacin (MOXIGEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01936480
Recruitment Status : Enrolling by invitation
First Posted : September 6, 2013
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Christopher Newton-Cheh, MD, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to assess the ability of common genetic variants in aggregate to predict drug-induced QT prolongation in healthy subjects using moxifloxacin.

Condition or disease Intervention/treatment Phase
Cardiac Arrhythmias Drug: Moxifloxacin 400mg once time Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Genetics of QT Response to Moxifloxacin
Study Start Date : October 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Moxifloxacin group
Healthy volunteers with QT genotype score in the highest or lowest quintile
Drug: Moxifloxacin 400mg once time
Other Name: Avelox
Placebo Comparator: Placebo Group
Healthy volunteers with QT genotype score in the highest or lowest quintile
Drug: Placebo



Primary Outcome Measures :
  1. QT interval duration [ Time Frame: 6 Hours ]
    We will measure the QT interval on ECG up to 6 hours after administration of moxifloxacin or placebo



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Genotype in the highest and lowest quintiles of genetic predictors of QT interval duration
  • Able to swallow pills

Exclusion Criteria:

  • Inability to provide informed consent
  • Prior known cardiovascular, renal, hepatic disease
  • Personal or family history of sudden cardiac death
  • Current use of prescribed or over-the-counter medications as well as recreational drugs
  • Resting bradycardia (defined as resting heart rate < 50 bpm)
  • Conduction disease (QRS > 100ms)
  • QTc prolongation on electrocardiography (QTc > 500msec)
  • Abnormal potassium or magnesium serum level
  • Abnormal renal or liver function tests
  • Women who are nursing, pregnant or planning to become pregnant during the study period
  • Tendon disorder or rupture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936480


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Christopher Newton-Cheh, MD, MPH Massachusetts General Hospital

Responsible Party: Christopher Newton-Cheh, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01936480     History of Changes
Other Study ID Numbers: 2009A059013
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors