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

Jessica Ackert, Khadeeja Mohamed, Jason S. Slakter, Sherif El-Harazi, Alessandro Berni, Hakop Gevorkyan, Elizabeth Hardaker, Azra Hussaini, Siôn W. Jones, Gavin C. K. W. Koh, Jyoti Patel, Scott Rasmussen, Deborah S. Kelly, David E. Barañano, John T. Thompson, Keith A. Warren, Robert C. Sergott, John Tonkyn, Allen Wolstenholme, Hanna Coleman, Alex Yuan, Stephan Duparc and Justin A. Green ()
Additional contact information
Jessica Ackert: GlaxoSmithKline
Khadeeja Mohamed: GlaxoSmithKline Research and Development
Jason S. Slakter: Digital Angiography Reading Center (DARC)
Sherif El-Harazi: Lugene Eye Institute
Alessandro Berni: GlaxoSmithKline Research and Development Ltd.
Hakop Gevorkyan: California Clinical Trials Medical Group in affiliation with Parexel International
Elizabeth Hardaker: GlaxoSmithKline Research and Development
Azra Hussaini: PAREXEL, Harbor Hospital, Baltimore
Siôn W. Jones: GlaxoSmithKline Research and Development
Gavin C. K. W. Koh: GlaxoSmithKline Research and Development Ltd.
Jyoti Patel: GlaxoSmithKline Research and Development
Scott Rasmussen: IQVIA
Deborah S. Kelly: GlaxoSmithKline
David E. Barañano: Retina Specialists
John T. Thompson: Retina Specialists
Keith A. Warren: IQVIA
Robert C. Sergott: Wills Eye Hospital
John Tonkyn: GlaxoSmithKline
Allen Wolstenholme: GlaxoSmithKline
Hanna Coleman: Digital Angiography Reading Center (DARC)
Alex Yuan: Digital Angiography Reading Center (DARC)
Stephan Duparc: Medicines for Malaria Venture
Justin A. Green: GlaxoSmithKline Research and Development Ltd.

Drug Safety, 2019, vol. 42, issue 9, No 8, 1103-1114

Abstract: 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 independent, masked reading center. Results One subject in each group met the composite primary endpoint for retinal changes identified with SD-OCT or FAF, i.e., one out of 306 (0.3%) with tafenoquine, one out of 161 (0.6%) with placebo. Both cases had unilateral focal ellipsoid zone disruption at day 90 with no effect on best-corrected visual acuity. The tafenoquine-treated subject had this abnormality at baseline, and was enrolled in error. There was no difference in ophthalmic safety between tafenoquine and placebo. Conclusion There was no evidence of any pharmacodynamic effect of 300-mg single-dose tafenoquine on the retina or any short-term clinically relevant effects on ophthalmic safety. This clinical trial is registered with ClinicalTrials.gov (identifier: NCT02658435).

Date: 2019
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DOI: 10.1007/s40264-019-00839-w

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