A RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, COMPARATIVE, MULTICENTER STUDY TO ASSESS THE INCIDENCE OF HEMOLYSIS, SAFETY, AND EFFICACY OF TAFENOQUINE (SB-252263, WR238605) VERSUS PRIMAQUINE IN THE TREATMENT OF SUBJECTS WITH PLASMODIUM VIVAX MALARIA

GlaxoSmithKline,0 sites100 target enrollmentNovember 13, 2014

Overview

No summary available.

Registry

who.int

Start Date

November 13, 2014

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

GlaxoSmithKline,

•1 A female is eligible to enter and participate in the study if she is non\-pregnant, non\-lactating and if she is of:
•a. Non\-childbearing potential defined as: post\-menopausal (12 months of spontaneous amenorrhea or \<6 months of spontaneous amenorrhea with serum FSH \>40 mIU/mL), or pre\-menopausal and has had a hysterectomy or a bilateral oophorectomy (removal of the ovaries) or a bilateral tubal ligation, negative pregnancy test or,
•b. Child\-bearing potential, has a negative pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 90 days after stopping study medication
•2\.The subject has a glucose 6\-phosphate dehydrogenase (G6PD) value (measured by a quantitative spectrophotometric phenotype assay) as follows:
•Female subjects must have an enzyme level ≥40% of the site median value for G6PD normal males.
•Male subjects must have an enzyme level ≥70% of the site median value for G6PD normal males.
•3\. The subject has a screening hemoglobin (Hb) value as follows:
•Any subject with a G6PD value ≥70% of the site median value must have a screening Hb value ≥7 g/dL.
•Female subjects with a G6PD value is ≥40% \- \<70% of the site median value must have a screening Hb value ≥8 g/dL
•4\.The subject has a QTcF of \<450 msec

•1\. The subject has a mixed malaria infection (identified by a malarial smear or rapid diagnostic test).
•2\. The subject has severe P. vivax malaria as defined by WHO criteria.
•3\. The subject has a history of allergy to chloroquine, mefloquine, tafenoquine, primaquine, or to any other 4\- or 8\-aminoquinoline
•4\. The subject has a liver ALT \>2 x ULN.
•5\. The subject has severe vomiting (no food or inability to take food during the previous 8 hours).
•6\. The subject has a clinically significant concurrent illness (e.g., pneumonia, septicemia), pre\-existing condition (e.g., renal disease, malignancy), condition that may affect absorption of study medication (e.g., vomiting, severe diarrhea), or clinical signs and symptoms of severe cardiovascular disease (e.g., uncontrolled congestive heart failure, severe coronary artery disease).
•7\. The subject has a history of porphyria, psoriasis, or epilepsy.
•8\. The subject has a history of significant ocular disease (e.g. surgery to the globe, glaucoma, diabetic retinopathy) or has evidence of corneal or retinal abnormalities identified in the clinical screening ophthalmologic examination.