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Tafenoquine Thorough QTc Study in Healthy Subjects

NCT01928914 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2017-06-12

No results posted yet for this study

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.

Conditions

  • Malaria, Vivax

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

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 NCT01928914 on ClinicalTrials.gov