NCT01353729

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

A Phase I, Randomized, Placebo-Controlled, Four-Way Crossover Study to Evaluate the Effect of Intravenous (IV) Zanamivir on Cardiac Conduction as Assessed by 12-lead Electrocardiogram (ECG) With Moxifloxacin as a Positive Control in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	600 mg zanamivir + moxifloxacin placebo	zanamivir 600 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose
DRUG	1200 mg zanamivir + moxifloxacin placebo	zanamivir 1200 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose
DRUG	zanamivir placebo + moxifloxacin placebo	zanamivir placebo IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose
DRUG	zanamivir placebo + 400 mg moxifloxacin	moxifloxacin 400 mg administered orally x 1 dose + zanamivir placebo IV over 30 min x 1 dose

Timeline

• Start date: 2011-05-19
• Primary completion: 2011-08-02
• Completion: 2011-08-02
• First posted: 2011-05-16
• Last updated: 2017-07-21

Locations

1 site across 1 country: United States