A Study to Evaluate the Effect of Intravenous Zanamivir on Cardiac Conduction in Healthy Volunteers

Summary

Approximately 40 healthy subjects will be enrolled. Each subject will participate in the study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each dosing period and will remain in the unit until Day 2. Each subject will receive a single dose of each of the four treatments on Day 1 of each treatment period in a randomized fashion. Subjects will be discharged from the clinical research unit after the completion of all assessments on Day 2 of each period and return approximately 5-7 days later for the next dose period. Serial pharmacokinetic samples will be collected for up to 24 hours following each treatment.

Timeline

Start

2011-05-19

Primary completion

2011-08-02

Completion

2011-08-02

Publications

• Background Lou Y, Gan J, Peppercorn A, Gould E, Weller S, Piscitelli SC, Patel P. Effect of intravenous zanamivir on cardiac repolarization. Pharmacotherapy. 2013 Jul;33(7):701-9. doi: 10.1002/phar.1261. Epub 2013 Apr 3.

Drugs

Indications