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A Randomized, Double-Blind, Safety and Tolerability Study to Assess the Ophthalmic and Renal Effects of Tafenoquine 200 mg Weekly versus Placebo for 6 Months in Healthy Volunteers

A randomized, double-blind, placebo-controlled study was conducted to assess the effect of tafenoquine, 200 mg weekly for 6 months on ophthalmic and renal safety. This trial was carried out after observations in previous clinical trials that tafenoquine may be associated with the development of corneal deposits and elevations in serum creatinine. In 120 healthy volunteers who received tafenoquine or placebo in a 2:1 randomization, there was no effect on night vision or other ophthalmic indices measured. Persons taking tafenoquine also showed no difference in mean change in glomerular filtration rate (GFR, mL/s/1.73 m²) after 6 months of dosing, with a treatment difference of –0.061 (95% confidence interval, –0.168, 0.045), and non-inferiority margin of –0.247 mL/s/1.73 m². Tafenoquine was well tolerated over the course of the study. The results of this study showed no clinically significant effects of tafenoquine on ophthalmic or renal function, and support its continued development as an antimalarial drug.

Received November 26, 2008. Accepted for publication March 29, 2009.

Financial support: This study was supported by GlaxoSmithKline (Brentford, Middlesex, UK) and the U.S. Army Medical Research and Materiel Command.

Disclaimer: This manuscript was reviewed by the Walter Reed Army Institute for Research and the United States Army Medical Research and Material Command. There is no objection to its publication or dissemination. The opinions expressed herein are those of the authors and do not necessarily reflect the official policy, position, or opinions of the Department of the Army, the Department of Defense, or the U.S. Government.

Disclosure: Some of the authors are employed by GlaxoSmithKline, which funded the study. This statement is made in the interest of full disclosure and not because the authors consider this a conflict of interest.

^* Address correspondence to Kevin Leary, United States Army Medical Materiel Development Activity, 1430 Veteran’s Drive, Fort Detrick, MD 21702-5009. E-mail: kevin.leary1{at}us.army.mil

Authors’ addresses: Kevin Leary, United States Army Medical Materiel Development Activity, 1430 Veteran’s Drive, Fort Detrick, MD 21702-5009, Tel: 301-619-1106, Fax: 301-619-2304, and Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814, Tel: 301-295-3239, Fax: 301-295-3976, E-mail: kevin.leary1{at}us.army.mil. Michael A. Riel, Michael J. Roy, Louis R. Cantilena, and Daoqin Bi, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814, Tel: 301-295-3239, Fax: 301-295-3976. D. Craig Brater, Indiana University School of Medicine, Fairbanks Hall 6200, 340 West 10 Street, Indianapolis, IN 46202, Tel: 317-274-8416, Fax: 317-274-8439. Corina van de Pol, Acufocus, Inc., 32 Discovery, Suite 200 Irvine, CA 92618, Tel: 949-585-9511, Fax: 949-585-9545. Khadeeja Pruett and Caron Kerr, GlaxoSmithKline Research and Development, Greenford Road, Greenford, Middlesex UB6 0HE, UK, Tel: +44-20-8422-3434, Fax: +44-20-8966-5285. James M. Veazey Jr, United States Army Medical Materiel Development Activity, 1430 Veteran’s Drive, Fort Detrick, MD 21702-5009, Tel: 301-619-1106, Fax: 301-619-2304. Ronnie Beboso, Chiltern (Early Phase) Limited Ninewells Hospital and Medical School Dundee DD1 9SY Scotland, U.K., Tel: +44 (0) 1382 646317, Fax: +44 (0) 1382 645606. Colin Ohrt, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910, Tel: 301-319-9280, Fax: 301-319-9449.