NCT01928914

Tafenoquine Thorough QTc Study in Healthy Subjects

A Randomized, Placebo-Controlled Study to Evaluate the Effect of Tafenoquine (SB252263) on the Electrocardiogram (ECG) With Focus on Cardiac Repolarization (QTc Duration) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

SB-252263 (tafenoquine, TQ) is a new 8-aminoquinoline antimalarial drug being developed by GlaxoSmithKline (GSK) and the Medicines for Malaria Venture with the assistance and historical support of the Walter Reed Army Institute of Research. Tafenoquine has been shown to be effective in the treatment of plasmodial infections in vitro, in pre-clinical models in vivo, and during early phase clinical studies for radical cure and eradication of liver hypnozoites in patients infected with Plasmodium vivax. This study is designed to compare the effects of tafenoquine mono-therapy, administered as a single dose or administered on 3 consecutive days, on the changes in QT duration to those observed in subjects dosed with either Avelox (moxifloxacin hydrochloride) or placebo. This will be a randomized, single-blind, placebo controlled, parallel group study. Parallel group design is chosen because tafenoquine has a long half-life, about 14 to 19 days, and therefore a cross-over design is not a practical alternative. Moxifloxacin will be used as a positive control in order to validate the sensitivity of the study in detecting QTc change. Moxifloxacin has been shown to prolong the QT interval in a dose-dependent manner in patients and healthy volunteers, and the QTc prolongation has been well quantified.

Conditions

• Malaria, Vivax

Interventions

Type	Name	Description
DRUG	Tafenoquine 300mg	Single dose of Tafenoquine give on Day 3 only
DRUG	Tafenoquine 600mg	Single dose of Tafenoquine given on Day 3 only
DRUG	Tafenoquine 1200mg	400mg Dose of Tafenoquine given on each of the three consecutive dosing days
DRUG	moxifloxacin	moxifloxacine given on Day 3 only
DRUG	Placebo for Tafenoquine	Placebo given on all three days to all groups except for group 5 on Day 3
DRUG	Placebo for moxifloxaxin	Placebo for moxifloxacin, given to all groups on all days except for Group 3 on Day 3

Timeline

• Start date: 2011-07-26
• Primary completion: 2012-06-04
• Completion: 2012-06-04
• First posted: 2013-08-27
• Last updated: 2017-06-12

Locations

2 sites across 1 country: United States