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

NCT01353729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-07-21

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-19
Primary Completion
2011-08-02
Completion
2011-08-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01353729 on ClinicalTrials.gov