Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT04709692
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2020-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}, {'id': 'D016780', 'term': 'Malaria, Vivax'}], 'ancestors': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597341', 'term': 'SJ733'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kip.guy@uky.edu', 'phone': '859-257-5290', 'title': 'R. Kiplin Guy', 'organization': 'University of Kentucky'}, 'certainAgreement': {'otherDetails': '1. All data or results arising out of the performance of this Study shall be considered Information as defined above and shall not be used for the commercial benefit of Institution, Investigator, or Research Staff.\n2. Any and all data resulting from the Study will not be presented or published in any form or media by the Institution, Investigator or Research Staff without the prior written consent of Sponsor which consent maybe as directed within the protocol.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'No participants were recruited into the P. falciparum arm as no participants who tested positive for P. falciparum met monoinfection inclusion criteria due to a decrease in P. falciparum monoinfection in the region.'}}, 'adverseEventsModule': {'timeFrame': 'AE data was collected for the 42 days that a participant was enrolled.', 'description': 'A standard physical examination was performed as per the study schedule and included: general appearance, head and eyes, ears, nose and throat, chest and lungs, cardiovascular, abdomen, neurological, lymphatic, and musculoskeletal. Vital signs, body temperature, and ECGs were taken per the study schedule. Participants were given contact information to self-report AEs between study visits.\n\nSigns and symptoms of malaria were not recorded as adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Food Poisoning', 'notes': 'MedDRA: 10016952 Severity: mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v2022AA'}, {'term': 'Hepatosplenomegaly', 'notes': 'MedDRA: 10019847 Severity: Mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v2022AA'}, {'term': 'Bilateral nephromegaly', 'notes': 'MedDRA: 10048469 Severity: Mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v2022AA'}, {'term': 'Alkaline Phosphatase Increase', 'notes': 'MedDRA: 10001675 Severity: Mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v2022AA'}, {'term': 'Acute pharyngitis', 'notes': 'MedDRA:10001002 Severity: Moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v2022AA'}, {'term': 'Increased Glucose', 'notes': 'MedDRA: 10018421 Severity: Mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v2022AA'}, {'term': 'Herpetic gingivostomatitis', 'notes': 'MedDRA: 10019996 Severity: Moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v2022AA'}], 'seriousEvents': [{'term': 'Febrile syndrome of probable viral etiology', 'notes': 'MedDRA code: 10072803 SAE due to Hospitalization - prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v2022AA'}, {'term': 'Severe Malaria Grade 4', 'notes': 'MedDRA: 10069722 Severe Malaria Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v2022AA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Crude Adequate Clinical and Parasitological Response (ACPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days for each arm', 'description': 'Crude Adequate Clinical and Parasitological Response (ACPR) defined as the absence of microscopically determined parasitemia (thick smear).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants eligible for efficacy analysis were analyzed.'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With Treatment Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days for each arm', 'description': 'Number of and seriousness of treatment related adverse events as defined in Adult Toxicity Tables', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With Clinically Significant Abnormal Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days for each arm', 'description': 'Number of and seriousness of clinically significant abnormal laboratory values including changes from baseline in (biochemistry and hematology)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With Clinically Significant Abnormal Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days for each arm', 'description': 'Number of and seriousness of clinically significant abnormal vital signs including changes from baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With a Decrease in Hemoglobin (HB) > 2 g/dL From Baseline to an Absolute Value of < 5 g/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': 'Percent of patients with a decrease in hemoglobin (HB) \\> 2 g/dL from baseline to an absolute value of \\< 5 g/dL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With an Absolute Neutrophil Count < 1,000/μL After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': 'Percent of patients with an absolute Neutrophil count \\< 1,000/μL after baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Percent of Patients Meeting Hy's Law Criteria", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': "Percent of patients meeting Hy's law criteria. Hy's law criteria: (1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation of \\>3× the upper limit of normal (ULN); (2) total bilirubin (TBL) elevation of \\>2× ULN; (3) absence of initial findings of cholestasis (ie, absence of elevation of alkaline phosphatase \\[ALP\\] to \\>2× ULN); and (4) no other reason can be found to explain the combination of increased ALT and TBL, such as viral hepatitis A through E; other preexisting or acute liver disease; or another drug capable of causing the observed injury.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With Any ALT or AST ≥ 5 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': 'Percent of patients with Any ALT or AST ≥ 5 x upper limit of normal (ULN)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With a ny AST or ALT ≥ 3 x ULN Together With the Appearance of Fatigue, Nausea, Vomiting, Right Upper Quadrant Pain or Tenderness, Fever, Rash and/or Eosinophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': 'Percent of patients with any AST or ALT ≥ 3 x ULN together with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia (eosinophil percent or count above the upper limit of normal (ULN))', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With Persistent ALT ≥ 3 x ULN for a Period of More Than 4 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': 'Percent of patients with persistent ALT ≥ 3 x ULN for a period of more than 4 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With Clinical Signs of Possible Cutaneous Adverse Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': 'Percent of patients with clinical signs of possible cutaneous adverse reactions such as dermatitis, rash, erythematous rash, macular rash, papular rash, maculo-papular rash, pruritic rash, pustular rash, vesicular rash', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With Clinically Significant Increases in Venous Methemoglobin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': 'Percent of patients with clinically significant increases in venous methemoglobin levels', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Patients With Significant Changes in ECG Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days', 'description': 'Percent of patients with significant changes in ECG findings, including heart rate, ECG intervals (PR, QTcB, QTcF), conduction changes or abnormalities', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Signs and Symptoms of Uncomplicated Malaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days for each arm', 'description': 'Number of participants with symptoms (including fever) or physical examination signs related to uncomplicated P. vivax or P. falciparum malaria', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parasite Clearance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '15.60', 'groupId': 'OG000', 'lowerLimit': '10.45', 'upperLimit': '20.75'}, {'value': '45.78', 'groupId': 'OG001', 'lowerLimit': '15.83', 'upperLimit': '75.73'}]}]}], 'paramType': 'MEAN', 'timeFrame': '42 days for each arm', 'description': 'Time to parasite clearance as measured by microscopy', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants eligible for efficacy measurements were analyzed.'}, {'type': 'SECONDARY', 'title': 'Parasite Reduction Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000', 'lowerLimit': '-0.39', 'upperLimit': '-0.27'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.09', 'upperLimit': '-0.06'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0->96 h, depending upon the time required to reach lower limit of detection', 'description': 'The parasite reduction rate is calculated as the slope of the linear portion of the regression fit of natural log of average parasitemia (per microliter) versus time (in hours). Reported slope is representative of all analyzed participants in each arm. Slope is analyzed during time frame in which there is active reduction of parasitemia by treatment (0-\\>96 h).', 'unitOfMeasure': 'Ln(parasites/uL)/hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants eligible for efficacy analysis were analyzed'}, {'type': 'SECONDARY', 'title': 'Asexual Parasite Clearance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '15.60', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '45.78', 'spread': '48.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '42 days for each arm', 'description': 'Time to clearance of asexual parasites as measured by microscopy including half life of clearance. Clearance time represents the time at which the mean parasitemia has reached the given threshold for the arm/cohort. For PC100, the value represents the time at which all patients have undetectable parasitemia.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who were eligible for efficacy analysis were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Asexual Parasites From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'title': 'Percent change in asexual parasites from baseline (24h)', 'categories': [{'measurements': [{'value': '-100', 'spread': '0', 'groupId': 'OG000'}, {'value': '-97', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': 'Percent change in asexual parasites from baseline (48h)', 'categories': [{'measurements': [{'value': '-100', 'spread': '0', 'groupId': 'OG000'}, {'value': '-99.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Percent change in asexual parasites from baseline (72h)', 'categories': [{'measurements': [{'value': '-100', 'spread': '0', 'groupId': 'OG000'}, {'value': '-99.8', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '42 days', 'description': 'Percentage change of asexual parasites as determined by microscopy, relative to baseline at the specified times. The value represents the average parasitemia in the arm/cohort at the given time (per microliter) versus time (in hours) compared to the average parasitemia at T0. Reported reduction is representative of all analyzed participants in each arm.', 'unitOfMeasure': 'percentage change in parasites', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only data from participants who were eligible for efficacy analysis were analyzed.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'title': 'AUC SJ733 at 24 hours', 'categories': [{'measurements': [{'value': '110325', 'groupId': 'OG000', 'lowerLimit': '43668.7', 'upperLimit': '152576'}, {'value': '24688.1', 'groupId': 'OG001', 'lowerLimit': '14619.3', 'upperLimit': '53068.5'}]}]}, {'title': 'AUC SJ506 at 24 hours', 'categories': [{'measurements': [{'value': '14123.7', 'groupId': 'OG000', 'lowerLimit': '10503.9', 'upperLimit': '22190.3'}, {'value': '31793.6', 'groupId': 'OG001', 'lowerLimit': '20351.4', 'upperLimit': '53646.8'}]}]}, {'title': 'AUC SJ733 at 48 hours', 'categories': [{'measurements': [{'value': '271632.1', 'groupId': 'OG000', 'lowerLimit': '110789.6', 'upperLimit': '453783.7'}, {'value': '56991.9', 'groupId': 'OG001', 'lowerLimit': '32603.6', 'upperLimit': '123993'}]}]}, {'title': 'AUC SJ506 at 48 hours', 'categories': [{'measurements': [{'value': '29341.8', 'groupId': 'OG000', 'lowerLimit': '25847.4', 'upperLimit': '49196.8'}, {'value': '74646.5', 'groupId': 'OG001', 'lowerLimit': '45931.0', 'upperLimit': '135353'}]}]}, {'title': 'AUC SJ733 at 72 hours', 'categories': [{'measurements': [{'value': '450506.3', 'groupId': 'OG000', 'lowerLimit': '183096.6', 'upperLimit': '803489.9'}, {'value': '92110.9', 'groupId': 'OG001', 'lowerLimit': '51343.5', 'upperLimit': '199588'}]}]}, {'title': 'AUC SJ506 at 72 hours', 'categories': [{'measurements': [{'value': '46477.5', 'groupId': 'OG000', 'lowerLimit': '42653.0', 'upperLimit': '83301.5'}, {'value': '118717', 'groupId': 'OG001', 'lowerLimit': '72347.5', 'upperLimit': '222926'}]}]}, {'title': 'AUC SJ733 at 96 hours', 'categories': [{'measurements': [{'value': '517702.6', 'groupId': 'OG000', 'lowerLimit': '203441.3', 'upperLimit': '899838.3'}, {'value': '105105.4', 'groupId': 'OG001', 'lowerLimit': '55298.7', 'upperLimit': '224240'}]}]}, {'title': 'AUC SJ506 at 96 hours', 'categories': [{'measurements': [{'value': '73619.8', 'groupId': 'OG000', 'lowerLimit': '59668.9', 'upperLimit': '136436'}, {'value': '134468', 'groupId': 'OG001', 'lowerLimit': '79329.6', 'upperLimit': '258502'}]}]}, {'title': 'AUC SJ733 at infinity', 'categories': [{'measurements': [{'value': '538769.3', 'groupId': 'OG000', 'lowerLimit': '207509.5', 'upperLimit': '927069.4'}, {'value': '111850', 'groupId': 'OG001', 'lowerLimit': '56459.1', 'upperLimit': '234779'}]}]}, {'title': 'AUC SJ506 at infinity', 'categories': [{'measurements': [{'value': '93372.4', 'groupId': 'OG000', 'lowerLimit': '65738.8', 'upperLimit': '176802'}, {'value': '141447', 'groupId': 'OG001', 'lowerLimit': '82004.8', 'upperLimit': '273535'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '11 days for each arm', 'description': 'AUC of SJ733 and its metabolite SJ506 will be reported', 'unitOfMeasure': 'ug*h/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm 2B participant whose condition worsened to severe malaria was not included in analysis due to no data available.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Drug Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'title': 'Cmax SJ733', 'categories': [{'measurements': [{'value': '9207.6', 'groupId': 'OG000', 'lowerLimit': '3697.3', 'upperLimit': '17736'}, {'value': '2730.3', 'groupId': 'OG001', 'lowerLimit': '1257.8', 'upperLimit': '5032.7'}]}]}, {'title': 'Cmax SJ506', 'categories': [{'measurements': [{'value': '1244', 'groupId': 'OG000', 'lowerLimit': '898.6', 'upperLimit': '2424'}, {'value': '2918.2', 'groupId': 'OG001', 'lowerLimit': '1907.0', 'upperLimit': '4602.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '11 days for each arm', 'description': 'Cmax of SJ733 and its metabolite SJ506 will be reported', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm 2B participant whose condition worsened to severe malaria was not included in analysis due to no data available.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '53.97', 'groupId': 'OG000', 'lowerLimit': '52.02', 'upperLimit': '55.31'}, {'value': '49.03', 'groupId': 'OG001', 'lowerLimit': '48.57', 'upperLimit': '55.12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '11 days for each arm', 'description': 'Time to reach maximum plasma concentration (Tmax) of SJ733 will be reported', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm 2B participant whose condition worsened to severe malaria was not included in analysis as there was no data available.'}, {'type': 'SECONDARY', 'title': 'Drug Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'title': 'CL SJ733', 'categories': [{'measurements': [{'value': '4.51', 'groupId': 'OG000', 'lowerLimit': '3.14', 'upperLimit': '15.69'}, {'value': '16.06', 'groupId': 'OG001', 'lowerLimit': '7.69', 'upperLimit': '31.83'}]}]}, {'title': 'CL SJ506', 'categories': [{'measurements': [{'value': '19.49', 'groupId': 'OG000', 'lowerLimit': '10.19', 'upperLimit': '27.74'}, {'value': '12.95', 'groupId': 'OG001', 'lowerLimit': '6.68', 'upperLimit': '22.41'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '11 days for each arm', 'description': 'Drug clearance of SJ733 and its metabolite SJ506 will be reported', 'unitOfMeasure': 'L/h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Arm 2B participant whose condition progressed to severe malaria was not included in analysis as no PK data was collected.'}, {'type': 'SECONDARY', 'title': 'Crude Adequate Clinical and Parasitological Response (ACPR) at Days 28, 35, and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'title': 'ACPR day 28', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'ACPR day 35', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'ACPR day 42', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '42 days for each arm', 'description': 'Crude Adequate Clinical and Parasitological Response (ACPR) at Days 28, 35, and 42 as measured by microscopy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "One participant from Arm 2b voluntarily withdrew from the study before the 14 day primary ACPR measurement. That participant's data is not included.\n\nOne participant from Arm 2b developed severe malaria within hours after the first dose of SJ733. The participant received local treatment of standard of care for severe malaria. That participant's data is not included."}, {'type': 'SECONDARY', 'title': 'Time to Recurrence of Malaria Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '9.51', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '8.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '42 days for each arm', 'description': 'Time to recurrence of either P. vivax or P. falciparum malaria as measured by signs and symptoms or malaria and microscopy', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who were eligible for efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Fever Clearance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '9.200', 'groupId': 'OG000', 'lowerLimit': '5.373', 'upperLimit': '13.03'}, {'value': '6.667', 'groupId': 'OG001', 'lowerLimit': '4.004', 'upperLimit': '9.329'}]}]}], 'paramType': 'MEAN', 'timeFrame': '42 days for each arm', 'description': 'Time from baseline to the first of two consecutive post-dose auxiliary temperature measurements \\< 37.5 C obtained within an interval of 4 to 24 hours of each other', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes all eligible participants, including (in arm 2B) one participant who developed severe malaria.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Crude Adequate Clinical and Parasitological Response (ACPR), PCR Adjusted, at Days 7, 14, 28, 35, and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'title': 'ACPR 7', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'ACPR 14', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'ACPR 28', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'ACPR 35', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'ACPR 42', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '42 days for each arm', 'description': 'Crude Adequate Clinical and Parasitological Response (ACPR) as adjusted by quantitative PCR of parasite DNA at Days 7, 14, 28, 35, and 42', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Does not include Arm 2B participant who withdrew before day 14 nor Arm 2B participant who developed severe malaria and was treated with local standard of care for severe malaria.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Recurrence of Malaria Infection, PCR Adjusted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'OG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '9.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '42 days for each arm', 'description': 'Time to recurrence of either P. vivax or P. falciparum malaria as measured by PCR', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants eligible for efficacy analysis were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'FG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1 B (Cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'BG001', 'title': 'Arm 2 B (Cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax\n\n(+)-SJ000557733 (SJ733): Anti-Malarial'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '12.47', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '12.87', 'groupId': 'BG001'}, {'value': '40.6', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Peru', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-02', 'size': 1170389, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-05-08T17:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'There are 6 treatment arms (three cohorts, each with P. falciparum and P.vivax arms).Cohort progression will be managed independently for each treatment arm. Interim analysis will determine whether the data for each arm meets the success criteria'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2020-12-15', 'resultsFirstSubmitDate': '2023-04-13', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-30', 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Crude Adequate Clinical and Parasitological Response (ACPR), PCR Adjusted, at Days 7, 14, 28, 35, and 42', 'timeFrame': '42 days for each arm', 'description': 'Crude Adequate Clinical and Parasitological Response (ACPR) as adjusted by quantitative PCR of parasite DNA at Days 7, 14, 28, 35, and 42'}, {'measure': 'Time to Recurrence of Malaria Infection, PCR Adjusted', 'timeFrame': '42 days for each arm', 'description': 'Time to recurrence of either P. vivax or P. falciparum malaria as measured by PCR'}], 'primaryOutcomes': [{'measure': 'Crude Adequate Clinical and Parasitological Response (ACPR)', 'timeFrame': '14 days for each arm', 'description': 'Crude Adequate Clinical and Parasitological Response (ACPR) defined as the absence of microscopically determined parasitemia (thick smear).'}, {'measure': 'Percent of Patients With Treatment Related Adverse Events', 'timeFrame': '42 days for each arm', 'description': 'Number of and seriousness of treatment related adverse events as defined in Adult Toxicity Tables'}, {'measure': 'Percent of Patients With Clinically Significant Abnormal Laboratory Values', 'timeFrame': '42 days for each arm', 'description': 'Number of and seriousness of clinically significant abnormal laboratory values including changes from baseline in (biochemistry and hematology)'}, {'measure': 'Percent of Patients With Clinically Significant Abnormal Vital Signs', 'timeFrame': '42 days for each arm', 'description': 'Number of and seriousness of clinically significant abnormal vital signs including changes from baseline'}, {'measure': 'Percent of Patients With a Decrease in Hemoglobin (HB) > 2 g/dL From Baseline to an Absolute Value of < 5 g/dL', 'timeFrame': '42 days', 'description': 'Percent of patients with a decrease in hemoglobin (HB) \\> 2 g/dL from baseline to an absolute value of \\< 5 g/dL'}, {'measure': 'Percent of Patients With an Absolute Neutrophil Count < 1,000/μL After Baseline', 'timeFrame': '42 days', 'description': 'Percent of patients with an absolute Neutrophil count \\< 1,000/μL after baseline'}, {'measure': "Percent of Patients Meeting Hy's Law Criteria", 'timeFrame': '42 days', 'description': "Percent of patients meeting Hy's law criteria. Hy's law criteria: (1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation of \\>3× the upper limit of normal (ULN); (2) total bilirubin (TBL) elevation of \\>2× ULN; (3) absence of initial findings of cholestasis (ie, absence of elevation of alkaline phosphatase \\[ALP\\] to \\>2× ULN); and (4) no other reason can be found to explain the combination of increased ALT and TBL, such as viral hepatitis A through E; other preexisting or acute liver disease; or another drug capable of causing the observed injury."}, {'measure': 'Percent of Patients With Any ALT or AST ≥ 5 x ULN', 'timeFrame': '42 days', 'description': 'Percent of patients with Any ALT or AST ≥ 5 x upper limit of normal (ULN)'}, {'measure': 'Percent of Patients With a ny AST or ALT ≥ 3 x ULN Together With the Appearance of Fatigue, Nausea, Vomiting, Right Upper Quadrant Pain or Tenderness, Fever, Rash and/or Eosinophilia', 'timeFrame': '42 days', 'description': 'Percent of patients with any AST or ALT ≥ 3 x ULN together with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia (eosinophil percent or count above the upper limit of normal (ULN))'}, {'measure': 'Percent of Patients With Persistent ALT ≥ 3 x ULN for a Period of More Than 4 Weeks.', 'timeFrame': '42 days', 'description': 'Percent of patients with persistent ALT ≥ 3 x ULN for a period of more than 4 weeks.'}, {'measure': 'Percent of Patients With Clinical Signs of Possible Cutaneous Adverse Reactions', 'timeFrame': '42 days', 'description': 'Percent of patients with clinical signs of possible cutaneous adverse reactions such as dermatitis, rash, erythematous rash, macular rash, papular rash, maculo-papular rash, pruritic rash, pustular rash, vesicular rash'}, {'measure': 'Percent of Patients With Clinically Significant Increases in Venous Methemoglobin Levels', 'timeFrame': '42 days', 'description': 'Percent of patients with clinically significant increases in venous methemoglobin levels'}, {'measure': 'Percent of Patients With Significant Changes in ECG Findings', 'timeFrame': '42 days', 'description': 'Percent of patients with significant changes in ECG findings, including heart rate, ECG intervals (PR, QTcB, QTcF), conduction changes or abnormalities'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Signs and Symptoms of Uncomplicated Malaria', 'timeFrame': '42 days for each arm', 'description': 'Number of participants with symptoms (including fever) or physical examination signs related to uncomplicated P. vivax or P. falciparum malaria'}, {'measure': 'Parasite Clearance Time', 'timeFrame': '42 days for each arm', 'description': 'Time to parasite clearance as measured by microscopy'}, {'measure': 'Parasite Reduction Rate', 'timeFrame': '0->96 h, depending upon the time required to reach lower limit of detection', 'description': 'The parasite reduction rate is calculated as the slope of the linear portion of the regression fit of natural log of average parasitemia (per microliter) versus time (in hours). Reported slope is representative of all analyzed participants in each arm. Slope is analyzed during time frame in which there is active reduction of parasitemia by treatment (0-\\>96 h).'}, {'measure': 'Asexual Parasite Clearance Time', 'timeFrame': '42 days for each arm', 'description': 'Time to clearance of asexual parasites as measured by microscopy including half life of clearance. Clearance time represents the time at which the mean parasitemia has reached the given threshold for the arm/cohort. For PC100, the value represents the time at which all patients have undetectable parasitemia.'}, {'measure': 'Percent Change in Asexual Parasites From Baseline', 'timeFrame': '42 days', 'description': 'Percentage change of asexual parasites as determined by microscopy, relative to baseline at the specified times. The value represents the average parasitemia in the arm/cohort at the given time (per microliter) versus time (in hours) compared to the average parasitemia at T0. Reported reduction is representative of all analyzed participants in each arm.'}, {'measure': 'Area Under the Plasma Concentration-time Curve (AUC)', 'timeFrame': '11 days for each arm', 'description': 'AUC of SJ733 and its metabolite SJ506 will be reported'}, {'measure': 'Maximum Plasma Drug Concentration (Cmax)', 'timeFrame': '11 days for each arm', 'description': 'Cmax of SJ733 and its metabolite SJ506 will be reported'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax)', 'timeFrame': '11 days for each arm', 'description': 'Time to reach maximum plasma concentration (Tmax) of SJ733 will be reported'}, {'measure': 'Drug Clearance', 'timeFrame': '11 days for each arm', 'description': 'Drug clearance of SJ733 and its metabolite SJ506 will be reported'}, {'measure': 'Crude Adequate Clinical and Parasitological Response (ACPR) at Days 28, 35, and 42', 'timeFrame': '42 days for each arm', 'description': 'Crude Adequate Clinical and Parasitological Response (ACPR) at Days 28, 35, and 42 as measured by microscopy.'}, {'measure': 'Time to Recurrence of Malaria Infection', 'timeFrame': '42 days for each arm', 'description': 'Time to recurrence of either P. vivax or P. falciparum malaria as measured by signs and symptoms or malaria and microscopy'}, {'measure': 'Fever Clearance Time', 'timeFrame': '42 days for each arm', 'description': 'Time from baseline to the first of two consecutive post-dose auxiliary temperature measurements \\< 37.5 C obtained within an interval of 4 to 24 hours of each other'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malaria, Falciparum', 'Malaria, Vivax']}, 'referencesModule': {'references': [{'pmid': '25453091', 'type': 'BACKGROUND', 'citation': "Jimenez-Diaz MB, Ebert D, Salinas Y, Pradhan A, Lehane AM, Myrand-Lapierre ME, O'Loughlin KG, Shackleford DM, Justino de Almeida M, Carrillo AK, Clark JA, Dennis AS, Diep J, Deng X, Duffy S, Endsley AN, Fedewa G, Guiguemde WA, Gomez MG, Holbrook G, Horst J, Kim CC, Liu J, Lee MC, Matheny A, Martinez MS, Miller G, Rodriguez-Alejandre A, Sanz L, Sigal M, Spillman NJ, Stein PD, Wang Z, Zhu F, Waterson D, Knapp S, Shelat A, Avery VM, Fidock DA, Gamo FJ, Charman SA, Mirsalis JC, Ma H, Ferrer S, Kirk K, Angulo-Barturen I, Kyle DE, DeRisi JL, Floyd DM, Guy RK. (+)-SJ733, a clinical candidate for malaria that acts through ATP4 to induce rapid host-mediated clearance of Plasmodium. Proc Natl Acad Sci U S A. 2014 Dec 16;111(50):E5455-62. doi: 10.1073/pnas.1414221111. Epub 2014 Dec 1."}, {'pmid': '32275867', 'type': 'BACKGROUND', 'citation': 'Gaur AH, McCarthy JS, Panetta JC, Dallas RH, Woodford J, Tang L, Smith AM, Stewart TB, Branum KC, Freeman BB 3rd, Patel ND, John E, Chalon S, Ost S, Heine RN, Richardson JL, Christensen R, Flynn PM, Van Gessel Y, Mitasev B, Mohrle JJ, Gusovsky F, Bebrevska L, Guy RK. Safety, tolerability, pharmacokinetics, and antimalarial efficacy of a novel Plasmodium falciparum ATP4 inhibitor SJ733: a first-in-human and induced blood-stage malaria phase 1a/b trial. Lancet Infect Dis. 2020 Aug;20(8):964-975. doi: 10.1016/S1473-3099(19)30611-5. Epub 2020 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'This Phase 2a trial recruits adult patients with uncomplicated P. vivax or P. falciparum blood-stage malaria mono-infection. The study drug SJ733 will be administered to examine its antimalarial efficacy, safety, and tolerability. This study also evaluates whether or not a fixed dose of the pharmacoenhancer cobicistat when given in combination with SJ733 significantly improves drug efficacy.', 'detailedDescription': 'This is an adaptive open label Phase 2a study to examine the antimalarial efficacy, safety, and tolerability of SJ733 in adult patients with uncomplicated P. vivax or P. falciparum blood-stage malaria monoinfection. SJ733 will be administered orally once every day for three consecutive days, with or without a fixed dose of the pharmacoenhancer cobicistat. The Phase 1 clinical data (completed under a US IND) and PK/PD models suggest that SJ733 is most likely to be curative as a 3-daily-dose pharmacoenhanced therapy, due to its moderately rapid clearance. There will be 1-3 cohorts with each cohort containing two treatment arms, P. falciparum (a) and P. vivax (b). Cohort progression will be managed independently for each treatment arm. Interim analysis will determine whether the data for a given treatment arm meets the success criteria, is inconclusive, or meets the failure criteria. Antimalarial efficacy will be examined over the period of 42 days. Additional aims are to characterize the safety and pharmacokinetics of SJ733. The results of this trial will identify active, well-tolerated doses for investigation in a larger Phase 2b clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female, aged 18 to 70 years of age (inclusive) at screening.\n2. Body weight between 45 kg and 90 kg inclusive\n3. Presence of mono-infection of P. falciparum or P. vivax confirmed by:\n\n 1. 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,\n 2. Microscopically confirmed parasite infection: 1,000 to 40,000 asexual parasite count/µL blood\n4. 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.\n5. Ability to swallow oral medication.\n6. Ability and willingness to participate and to comply with the study requirements\n7. Agreement to hospitalization for at least 102 hours and/or until malarial parasites are not detected by microscopy on 2 consecutive occasions.\n8. Agreement to come back to the hospital on Days 7, 10 or 11, 14, 17 or 18, 21, 24 or 25, 28, 35, and 42.\n9. Women of 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 drug:\n\n 1. Use of oral, implantable, or injectable hormonal contraceptive, either combined or progestogen alone used in conjunction with barrier method as defined below.\n 2. Use of an intrauterine device with a documented failure rate of \\<1% per year.\n 3. Barrier method consisting of either condom or diaphragm.\n 4. Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female.\n 5. Complete abstinence from intercourse for 2 weeks prior to administration of study drug, throughout the study and for a period of 90 days after stopping study drug.\n\nExclusion Criteria:\n\n1. Signs and symptoms of severe/complicated malaria according to the World Health Organization Criteria 2010 (Attachment 1: Definition of Severe Malaria)\n2. Mixed Plasmodium infection.\n3. Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study, or severe diarrhea defined as 3 or more watery stools per day.\n4. 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)\n5. 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.\n6. Female patients must not be either 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).\n7. Employment under the direct supervision of the investigators or study staff.\n8. Clinically significant alterations to hematologic or clinical chemistry parameters that in the opinion of the investigator precludes participation in the study, including:\n\n 1. AST/ALT \\> 3 x upper limit of normal range (ULN) and total bilirubin is normal\n 2. AST/ALT \\> 2 x ULN and total bilirubin is \\>1 and \\<1.5 x ULN and conjugated bilirubin is \\> 35% of the total bilirubin\n 3. Total bilirubin \\> 1.5 x ULN\n 4. Serum creatinine levels \\> 2 x ULN\n 5. Hb level \\< 8 g/dL\n 6. Platelet level \\< 50,000/mm3\n9. Participation in a clinical study of another investigational small molecule within 30 days or investigational biologic within 90 days prior to study enrollment or planning to begin such participation during the study.\n10. Have received any antimalarial treatment (alone or in combination) in the past containing:\n\n 1. Piperaquine, mefloquine, naphthoquine or sulphadoxine / pyrimethamine within the previous 6 weeks\n 2. Amodiaquine or chloroquine within the previous 4 weeks\n 3. 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 14 days\n11. Any medication from the list of prohibited medications."}, 'identificationModule': {'nctId': 'NCT04709692', 'briefTitle': 'Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'An Open Label Phase 2a Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of (+)-SJ000557733 (SJ733) With or Without Cobicistat in Adult Patients With Acute, Uncomplicated Malaria Over a 42 Day Period', 'orgStudyIdInfo': {'id': '53333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1 A (cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax', 'interventionNames': ['Drug: (+)-SJ000557733 (SJ733)']}, {'type': 'OTHER', 'label': 'Arm 1 B (cohort 1)', 'description': 'Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.falciparum', 'interventionNames': ['Drug: (+)-SJ000557733 (SJ733)']}, {'type': 'OTHER', 'label': 'Arm 2 A (cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax', 'interventionNames': ['Drug: (+)-SJ000557733 (SJ733)']}, {'type': 'OTHER', 'label': 'Arm 2 B (cohort 2)', 'description': '600 mg SJ733 administered orally once every day for three consecutive days for patients with P.falciparum', 'interventionNames': ['Drug: (+)-SJ000557733 (SJ733)']}, {'type': 'OTHER', 'label': 'Arm 3 A (cohort 3)', 'description': 'Combination of 300 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax', 'interventionNames': ['Drug: (+)-SJ000557733 (SJ733)']}, {'type': 'OTHER', 'label': 'Arm 3 B (cohort 3)', 'description': 'Combination of 300 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.falciparum', 'interventionNames': ['Drug: (+)-SJ000557733 (SJ733)']}], 'interventions': [{'name': '(+)-SJ000557733 (SJ733)', 'type': 'DRUG', 'otherNames': ['SJ733'], 'description': 'Anti-Malarial', 'armGroupLabels': ['Arm 1 A (cohort 1)', 'Arm 1 B (cohort 1)', 'Arm 2 A (cohort 2)', 'Arm 2 B (cohort 2)', 'Arm 3 A (cohort 3)', 'Arm 3 B (cohort 3)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Iquitos', 'state': 'Loreto', 'country': 'Peru', 'facility': 'Asociación Civil Selva Amazónica (ACSA)', 'geoPoint': {'lat': -3.74814, 'lon': -73.2529}}], 'overallOfficials': [{'name': 'Alejandro L Cuentas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación Civil Selva Amazónica (ACSA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R. Kiplin Guy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Global Health Innovative Technology Fund', 'class': 'OTHER'}, {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, {'name': 'Asociacion Civil Selva Amazonica', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Dean', 'investigatorFullName': 'R. Kiplin Guy', 'investigatorAffiliation': 'University of Kentucky'}}}}