This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria

Exclusion Criteria

• •Signs and symptoms of severe/complicated malaria according to the World Health Organization Criteria 2010.
• •Mixed Plasmodium infection or Plasmodium mono-infection with any Plasmodium species other than P. vivax.
• •Severe vomiting, defined as more than three times in the 24 hours prior to the planned first dose of drug, or severe diarrhea defined as 3 or more watery stools per day.
• •Severe malnutrition (defined as the weight-for-height being below -3 standard deviation or less than 70% of median of the NCHS/WHO normalized reference values).
• •The presence of a significant medical or psychiatric condition, or any other serious or chronic clinical condition requiring hospitalization, or any other condition that in the opinion of the investigator precludes participation in the study.
• •Female participants must not be lactating or pregnant as demonstrated by a negative serum point-of-care pregnancy test pre-dose (the result of the pre-dose assessment must be confirmed negative prior to dosing).
• •Employment under the direct supervision of the investigators or study staff.
• •Clinically significant alterations to hematologic or clinical chemistry parameters that in the opinion of the investigator precludes participation in the study, including:
• •1. AST/ALT \> 3 x upper limit of normal range (ULN) and total bilirubin is normal.
• •2. AST/ALT \> 2 x ULN and total bilirubin is \>1 and \<2 x ULN and conjugated bilirubin is \> 2x ULN.
• •3. Serum creatinine levels \> 2 x ULN
• •4. Uncorrected electrolyte abnormalities \[\> 3x ULN or LLN\]
• •i. Potassium\[hypokalemia\] ii. Magnesium \[hypomagnesemia\] e. Hb level \< 9 g/dL f. Platelet level \< 50,000/mm3
• •Clinically significant alterations to cardiac function
• •1. Unstable angina with elevated serum cardiac biomarkers, ECG changes, etc.; those with NSTE-ACS, NSTEMI, STEMI, or definite acute coronary syndrome.
• •2. Congestive heart failure
• •3. Recent history of Myocardial Infarction
• •4. QT prolongation (\>450 milliseconds (ms) in men and 460 ms in women)
• •Participation in a clinical study of another small investigational molecule within 30 days or investigational biologic within 90 days prior to study enrollment or planning to begin such participation during the study.
• •Received any antimalarial treatment (alone or in combination) in the past containing:
• •1. Tafenoquine within the previous 4 months
• •2. Piperaquine, mefloquine, naphthoquine or sulphadoxine / pyrimethamine within the previous 5 months
• •3. Amodiaquine or chloroquine within the previous 5 months
• •4. Any artemisinin (artesunate, artemether, arteether or dihydroartemisinin), quinine, halofantrine, lumefantrine and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 3 months.
• •Known history of hypersensitivity, allergic, or adverse reactions to SJ733, tafenoquine or other 8-aminoquinolines, or chloroquine or other 4-aminoquinolines.
• •Current use of prohibited concomitant medications (Appendix III)
• •Known neuropsychiatric disorders.
• •G6PD deficiency \<70% normal enzyme activity.
• •Prohibited use of metoclopramide, antibiotics including fluoroquinolones
• •Positive HIV and/or Hepatitis B, C test results