Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria

PHASE3CompletedINTERVENTIONAL
Enrollment

251

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

November 4, 2016

Study Completion Date

November 4, 2016

Conditions
Malaria, Vivax
Interventions
DRUG

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.

DRUG

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.

DRUG

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)."

DRUG

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.

DRUG

Primaquine Placebo

Placebo to match PQ will be supplied as Swedish orange size B supro capsules with common excipients of appropriate quality.

Trial Locations (10)

10400

GSK Investigational Site, Bangkok

63110

GSK Investigational Site, Mae Sot

63170

GSK Investigational Site, Tak

69040-000

GSK Investigational Site, Manaus

Unknown

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

Iqui 01

GSK Investigational Site, Iquitos

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Medicines for Malaria Venture

OTHER

lead

GlaxoSmithKline

INDUSTRY

NCT02216123 - Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria | Biotech Hunter | Biotech Hunter