To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects

Summary

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.

Timeline

Start

2011-08-16

Primary completion

2011-12-19

Completion

2011-12-19

Publications

• Al-Ramadan A, Kidess GG, Bahar AR, Bahar Y, Hazique M, Alraies M. Morbidity and Mortality of Ondansetron in Patients with Non-congenital Long QT Syndrome: A Review Article. Cardiovasc Drugs Ther. 2026 Jun;40(3):1117-1124. doi: 10.1007/s10557-025-07766-2. Epub 2025 Aug 26.

Drugs

Indications