Genetics of QT Response to Moxifloxacin

NCT01936480 | Terminated Phase 4

• 1 other identifier: 2013P001629
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (1)

• QT interval duration

  We will measure the QT interval on ECG up to 6 hours after administration of moxifloxacin or placebo

  6 Hours

Study Arms (2)

Moxifloxacin group

EXPERIMENTAL

Healthy volunteers with QT genotype score in the highest or lowest quintile

Drug: Moxifloxacin 400mg once time

Placebo group

PLACEBO COMPARATOR

Healthy volunteers with QT genotype score in the highest or lowest quintile

Drug: Moxifloxacin 400mg once time

Interventions

Moxifloxacin 400mg once time DRUG

Also known as: Avelox

Moxifloxacin group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christopher Newton-Cheh, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christopher Newton-Cheh, MD

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 6, 2013
• Study Start: October 1, 2013
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

US (1)