title: 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.
abstract: 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 m(2)) 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 m(2). 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.
authors.affiliation: United States Army Medical Materiel Development Activity, Fort Detrick, Maryland 21702-5009, USA. kevin.leary1@us.army.mil
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Leary
authors.forename: Michael A
authors.initials: MA
authors.lastname: Riel
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Roy
authors.forename: Louis R
authors.initials: LR
authors.lastname: Cantilena
authors.forename: Daoqin
authors.initials: D
authors.lastname: Bi
authors.forename: D Craig
authors.initials: DC
authors.lastname: Brater
authors.forename: Corina
authors.initials: C
authors.lastname: van de Pol
authors.forename: Khadeeja
authors.initials: K
authors.lastname: Pruett
authors.forename: Caron
authors.initials: C
authors.lastname: Kerr
authors.forename: James M
authors.initials: JM
authors.lastname: Veazey
authors.forename: Ronnie
authors.initials: R
authors.lastname: Beboso
authors.forename: Colin
authors.initials: C
authors.lastname: Ohrt
mesh_terms: D000293:Adolescent; D000328:Adult; D000634:Aminoquinolines / Q000009:adverse effects*; D000962:Antimalarials / Q000009:adverse effects*; D004311:Double-Blind Method; D005128:Eye Diseases / Q000139:chemically induced*; D005260:Female; D006801:Humans; D007674:Kidney Diseases / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged; D055254:Night Vision / Q000187:drug effects*; D055815:Young Adult
chemical_list: D000634:Aminoquinolines; D000962:Antimalarials; C055852:tafenoquine