The goal of this Phase 2b study is to examine the safety and efficacy of the combination of SJ733, an investigational agent, and tafenoquine for the radical cure of uncomplicated P. vivax malaria monoinfection in adult participants and determine the contributions of SJ733 to the effect. SJ733 will be administered in a 1-, 2-, or 3-day treatment schedule in combination with a single dose of tafenoquine.
Body weight between 45 kg and 90 kg inclusive.
Presence of mono-infection of P. vivax confirmed by: Fever, as defined by axillary temperature ≥ 37.5°C or oral/rectal/tympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and, Microscopically confirmed parasite infection: 1,000 to 40,000 asexual parasite count/µL blood
Written informed consent provided by participant, in accordance with local practice. If the participant is unable to write, witnessed consent is permitted according to local ethical considerations.
Ability to swallow oral medication.
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).
Parallel
SJ733/TQ placebo
DrugSJ733 combined with Tafenoquine Placebo
CQ/TQ Placebo
DrugChloroquine combined with Tafenoquine Placebo
CQ/TQ
DrugChloroquine combined with Tafenoquine
SJ733 (3-day)/TQ
DrugSJ733 (3-day schedule) combined with Tafenoquine
SJ733 (2-day ) /TQ
DrugSJ733 (2-day schedule) combined with Tafenoquine
SJ733(1-day)/TQ
DrugSJ733 (1 day schedule) combined with Tafenoquine
6
Treatment groupsSee each treatment group below.
Parasitological Recurrence Free survival (RFS)
Recurrence free survival (RFS), defined as non-relapses of P. vivax at 180 days given parasitemia clearance at 14 days.
Clinical Recurrence Free Survival
Absence of malaria-related clinical signs or symptoms over 180 days following confirmed parasitemia clearance at Day 14.
Percentage of patients with treatment related adverse events
Incidence, severity, drug-relatedness, and seriousness of adverse events
Percent of patients with clinically significant abnormal vital signs
Number of and seriousness of with clinically significant abnormal vital signs including changes from baseline
Number of participants with signs and symptoms of uncomplicated P. vivax malaria infection
Proportion of participants with symptoms or physical examination signs related to uncomplicated P. vivax malaria (e.g., headache, nausea, fatigue, fever auxiliary temperature, \>/= 37.5 C, chills/shivering/rigors, prostration, conjunctival jaundice, and respiratory distress)
Parasite clearance Time
Parasite Clearance Kinetics in participants with P. vivax malaria infection as measured by Microscopy
Area Under the Plasma Concentration Time Curve (AUC)
AUC of SJ733, its primary metabolite, SJ506, and tafenoquine
Maximum Plasma Concentration (Cmax)
Cmax of SJ733, its primary metabolite, SJ506, and tafenoquine
Correlation between microscopy and PCR measures of parasite clearance kinetics / efficacy
Effect of the proposed three-day therapy on PCR adjusted parasitological outcomes, complementing microscopy-based assessments, in participants with P. vivax malaria
Click on the lead sponsor to view all of their trials.
R. Kiplin Guy
Lead sponsor
University of Kentucky
Sponsor institution
Global Health Innovative Technology Fund
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
University of Minnesota
Collaborator
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