251
Participants
Start Date
April 30, 2015
Primary Completion Date
November 4, 2016
Study Completion Date
November 4, 2016
Tafenoquine
Tafenoquine will be supplied as a dark pink, capsule-shaped, film-coated tablet that is plain on both sides. Each tablet will contain 150mg TQ.
Tafenoquine Placebo
Placebo TQ tablets will be supplied as a dark pink, capsule-shaped, film-coated tablet that is plain on both sides, with common excipients of appropriate quality.
Chloroquine
"One of two formulations of commercially available generic chloroquine may be utilized in this study:~1. tablets containing 500 mg chloroquine phosphate (equivalent to 300 mg chloroquine free base); or,~2. tablets containing 250 mg chloroquine phosphate (equivalent to 155 mg chloroquine free base)."
Primaquine
Commercially available primaquine containing primaquine phosphate united states pharmacopeia (USP), 26.3 mg (equivalent to primaquine base 15 mg) will be utilized in this study. Primaquine, a pink film-coated tablet imprinted W on one side and P97 on the other side. The PQ tablets for this study have been over-encapsulated in a Swedish orange size B supro capsule.
Primaquine Placebo
Placebo to match PQ will be supplied as Swedish orange size B supro capsules with common excipients of appropriate quality.
GSK Investigational Site, Bangkok
GSK Investigational Site, Mae Sot
GSK Investigational Site, Tak
GSK Investigational Site, Manaus
GSK Investigational Site, Montería
GSK Investigational Site, Santiago de Cali
GSK Investigational Site, Gonder
GSK Investigational Site, Jimma
GSK Investigational Site, Ho Chi Minh City
GSK Investigational Site, Iquitos
Lead Sponsor
Medicines for Malaria Venture
OTHER
GlaxoSmithKline
INDUSTRY