Genetics of QT Response to Moxifloxacin

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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