Randomized Placebo-Controlled Trial Evaluating the Ophthalmic Safety of Single-Dose Tafenoquine in Healthy Volunteers.

ABSTRACT:

Introduction

Tafenoquine has been recently registered for the prevention of relapse in Plasmodium vivax malaria.

Objective

This study assessed the pharmacodynamic effects of 300-mg single-dose tafenoquine on the retina.

Methods

This phase I, prospective, multicenter, randomized, single-masked, placebo-controlled, parallel-group study was conducted between 2 February 2016 and 14 September 2017 at three US study centers. Adult healthy volunteers were randomized (2:1) to receive either a single 300-mg oral dose of tafenoquine or matched placebo on day 1. Ophthalmic assessments, including spectral domain optical coherence tomography (SD-OCT) and fundus autofluorescence (FAF), were conducted at baseline and day 90 and evaluated for pre-determined endpoints by an independen

SUBMITTER: Ackert J 

PROVIDER: S-EPMC6689320 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature