drugset / Trial / NCT01928914

Tafenoquine Thorough QTc Study in Healthy Subjects

NCT01928914

Phase 1 Completed 260 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindOther

Summary

This will be a randomized, single-blind, placebo controlled, parallel group study. Approximately 260 subjects will be enrolled in five groups. This study is designed to compare the effects of tafenoquine, administered as single dose as well as administered over three consecutive days, on the changes in QT duration to those observed in subjects dosed with either moxifloxacin or placebo.

Timeline

Start
2011-07-26
Primary completion
2012-06-04
Completion
2012-06-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Moxifloxacin Small molecule 400 mg
Subject Tafenoquine Small molecule 300 mg
Subject Tafenoquine Small molecule 400 mg
Subject Tafenoquine Small molecule 600 mg