Trial Outcomes & Findings for Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria (NCT NCT04709692)
NCT ID: NCT04709692
Last Updated: 2023-12-04
Results Overview
Crude Adequate Clinical and Parasitological Response (ACPR) defined as the absence of microscopically determined parasitemia (thick smear).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
14 days for each arm
Results posted on
2023-12-04
Participant Flow
Participant milestones
| Measure |
Arm 1 B (Cohort 1)
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria
Baseline characteristics by cohort
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 12.47 • n=99 Participants
|
42.9 years
STANDARD_DEVIATION 12.87 • n=107 Participants
|
40.6 years
STANDARD_DEVIATION 13.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Region of Enrollment
Peru
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 days for each armPopulation: Only participants eligible for efficacy analysis were analyzed.
Crude Adequate Clinical and Parasitological Response (ACPR) defined as the absence of microscopically determined parasitemia (thick smear).
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=9 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Crude Adequate Clinical and Parasitological Response (ACPR)
|
90 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: 42 days for each armNumber of and seriousness of treatment related adverse events as defined in Adult Toxicity Tables
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With Treatment Related Adverse Events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 days for each armNumber of and seriousness of clinically significant abnormal laboratory values including changes from baseline in (biochemistry and hematology)
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With Clinically Significant Abnormal Laboratory Values
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 42 days for each armNumber of and seriousness of clinically significant abnormal vital signs including changes from baseline
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With Clinically Significant Abnormal Vital Signs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 daysPercent of patients with a decrease in hemoglobin (HB) \> 2 g/dL from baseline to an absolute value of \< 5 g/dL
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With a Decrease in Hemoglobin (HB) > 2 g/dL From Baseline to an Absolute Value of < 5 g/dL
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 daysPercent of patients with an absolute Neutrophil count \< 1,000/μL after baseline
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With an Absolute Neutrophil Count < 1,000/μL After Baseline
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 daysPercent 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.
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients Meeting Hy's Law Criteria
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 daysPercent of patients with Any ALT or AST ≥ 5 x upper limit of normal (ULN)
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With Any ALT or AST ≥ 5 x ULN
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 daysPercent 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))
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 daysPercent of patients with persistent ALT ≥ 3 x ULN for a period of more than 4 weeks.
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With Persistent ALT ≥ 3 x ULN for a Period of More Than 4 Weeks.
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 daysPercent 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
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With Clinical Signs of Possible Cutaneous Adverse Reactions
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 daysPercent of patients with clinically significant increases in venous methemoglobin levels
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With Clinically Significant Increases in Venous Methemoglobin Levels
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 daysPercent of patients with significant changes in ECG findings, including heart rate, ECG intervals (PR, QTcB, QTcF), conduction changes or abnormalities
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent of Patients With Significant Changes in ECG Findings
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 42 days for each armNumber of participants with symptoms (including fever) or physical examination signs related to uncomplicated P. vivax or P. falciparum malaria
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Number of Participants With Signs and Symptoms of Uncomplicated Malaria
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 42 days for each armPopulation: Participants eligible for efficacy measurements were analyzed.
Time to parasite clearance as measured by microscopy
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=9 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Parasite Clearance Time
|
15.60 hours
Interval 10.45 to 20.75
|
45.78 hours
Interval 15.83 to 75.73
|
SECONDARY outcome
Timeframe: 0->96 h, depending upon the time required to reach lower limit of detectionPopulation: Participants eligible for efficacy analysis were analyzed
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).
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=9 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Parasite Reduction Rate
|
-0.33 Ln(parasites/uL)/hour
Interval -0.39 to -0.27
|
-0.08 Ln(parasites/uL)/hour
Interval -0.09 to -0.06
|
SECONDARY outcome
Timeframe: 42 days for each armPopulation: Only participants who were eligible for efficacy analysis were analyzed.
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.
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=9 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Asexual Parasite Clearance Time
|
15.60 hours
Standard Deviation 8.32
|
45.78 hours
Standard Deviation 48.33
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Only data from participants who were eligible for efficacy analysis were analyzed.
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.
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=9 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Percent Change in Asexual Parasites From Baseline
Percent change in asexual parasites from baseline (24h)
|
-100 percentage change in parasites
Standard Deviation 0
|
-97 percentage change in parasites
Standard Deviation 4.9
|
|
Percent Change in Asexual Parasites From Baseline
Percent change in asexual parasites from baseline (48h)
|
-100 percentage change in parasites
Standard Deviation 0
|
-99.5 percentage change in parasites
Standard Deviation 1.5
|
|
Percent Change in Asexual Parasites From Baseline
Percent change in asexual parasites from baseline (72h)
|
-100 percentage change in parasites
Standard Deviation 0
|
-99.8 percentage change in parasites
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 11 days for each armPopulation: Arm 2B participant whose condition worsened to severe malaria was not included in analysis due to no data available.
AUC of SJ733 and its metabolite SJ506 will be reported
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=11 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ733 at 24 hours
|
110325 ug*h/L
Interval 43668.7 to 152576.0
|
24688.1 ug*h/L
Interval 14619.3 to 53068.5
|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ506 at 24 hours
|
14123.7 ug*h/L
Interval 10503.9 to 22190.3
|
31793.6 ug*h/L
Interval 20351.4 to 53646.8
|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ733 at 48 hours
|
271632.1 ug*h/L
Interval 110789.6 to 453783.7
|
56991.9 ug*h/L
Interval 32603.6 to 123993.0
|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ506 at 48 hours
|
29341.8 ug*h/L
Interval 25847.4 to 49196.8
|
74646.5 ug*h/L
Interval 45931.0 to 135353.0
|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ733 at 72 hours
|
450506.3 ug*h/L
Interval 183096.6 to 803489.9
|
92110.9 ug*h/L
Interval 51343.5 to 199588.0
|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ506 at 72 hours
|
46477.5 ug*h/L
Interval 42653.0 to 83301.5
|
118717 ug*h/L
Interval 72347.5 to 222926.0
|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ733 at 96 hours
|
517702.6 ug*h/L
Interval 203441.3 to 899838.3
|
105105.4 ug*h/L
Interval 55298.7 to 224240.0
|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ506 at 96 hours
|
73619.8 ug*h/L
Interval 59668.9 to 136436.0
|
134468 ug*h/L
Interval 79329.6 to 258502.0
|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ733 at infinity
|
538769.3 ug*h/L
Interval 207509.5 to 927069.4
|
111850 ug*h/L
Interval 56459.1 to 234779.0
|
|
Area Under the Plasma Concentration-time Curve (AUC)
AUC SJ506 at infinity
|
93372.4 ug*h/L
Interval 65738.8 to 176802.0
|
141447 ug*h/L
Interval 82004.8 to 273535.0
|
SECONDARY outcome
Timeframe: 11 days for each armPopulation: Arm 2B participant whose condition worsened to severe malaria was not included in analysis due to no data available.
Cmax of SJ733 and its metabolite SJ506 will be reported
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=11 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Maximum Plasma Drug Concentration (Cmax)
Cmax SJ733
|
9207.6 ng/mL
Interval 3697.3 to 17736.0
|
2730.3 ng/mL
Interval 1257.8 to 5032.7
|
|
Maximum Plasma Drug Concentration (Cmax)
Cmax SJ506
|
1244 ng/mL
Interval 898.6 to 2424.0
|
2918.2 ng/mL
Interval 1907.0 to 4602.0
|
SECONDARY outcome
Timeframe: 11 days for each armPopulation: Arm 2B participant whose condition worsened to severe malaria was not included in analysis as there was no data available.
Time to reach maximum plasma concentration (Tmax) of SJ733 will be reported
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=11 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
|
53.97 hours
Interval 52.02 to 55.31
|
49.03 hours
Interval 48.57 to 55.12
|
SECONDARY outcome
Timeframe: 11 days for each armPopulation: Arm 2B participant whose condition progressed to severe malaria was not included in analysis as no PK data was collected.
Drug clearance of SJ733 and its metabolite SJ506 will be reported
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=11 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Drug Clearance
CL SJ733
|
4.51 L/h
Interval 3.14 to 15.69
|
16.06 L/h
Interval 7.69 to 31.83
|
|
Drug Clearance
CL SJ506
|
19.49 L/h
Interval 10.19 to 27.74
|
12.95 L/h
Interval 6.68 to 22.41
|
SECONDARY outcome
Timeframe: 42 days for each armPopulation: One participant from Arm 2b voluntarily withdrew from the study before the 14 day primary ACPR measurement. That participant's data is not included. One 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.
Crude Adequate Clinical and Parasitological Response (ACPR) at Days 28, 35, and 42 as measured by microscopy.
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=10 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Crude Adequate Clinical and Parasitological Response (ACPR) at Days 28, 35, and 42
ACPR day 28
|
20 percentage of participants
|
30 percentage of participants
|
|
Crude Adequate Clinical and Parasitological Response (ACPR) at Days 28, 35, and 42
ACPR day 35
|
20 percentage of participants
|
20 percentage of participants
|
|
Crude Adequate Clinical and Parasitological Response (ACPR) at Days 28, 35, and 42
ACPR day 42
|
20 percentage of participants
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: 42 days for each armPopulation: Includes participants who were eligible for efficacy analysis.
Time to recurrence of either P. vivax or P. falciparum malaria as measured by signs and symptoms or malaria and microscopy
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=9 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Time to Recurrence of Malaria Infection
|
25.0 days
Standard Deviation 9.51
|
24.1 days
Standard Deviation 8.95
|
SECONDARY outcome
Timeframe: 42 days for each armPopulation: Analysis includes all eligible participants, including (in arm 2B) one participant who developed severe malaria.
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
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Fever Clearance Time
|
9.200 hours
Interval 5.373 to 13.03
|
6.667 hours
Interval 4.004 to 9.329
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 42 days for each armPopulation: 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.
Crude Adequate Clinical and Parasitological Response (ACPR) as adjusted by quantitative PCR of parasite DNA at Days 7, 14, 28, 35, and 42
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=10 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Crude Adequate Clinical and Parasitological Response (ACPR), PCR Adjusted, at Days 7, 14, 28, 35, and 42
ACPR 7
|
100 percentage of participants
|
100 percentage of participants
|
|
Crude Adequate Clinical and Parasitological Response (ACPR), PCR Adjusted, at Days 7, 14, 28, 35, and 42
ACPR 14
|
80 percentage of participants
|
80 percentage of participants
|
|
Crude Adequate Clinical and Parasitological Response (ACPR), PCR Adjusted, at Days 7, 14, 28, 35, and 42
ACPR 28
|
20 percentage of participants
|
30 percentage of participants
|
|
Crude Adequate Clinical and Parasitological Response (ACPR), PCR Adjusted, at Days 7, 14, 28, 35, and 42
ACPR 35
|
20 percentage of participants
|
20 percentage of participants
|
|
Crude Adequate Clinical and Parasitological Response (ACPR), PCR Adjusted, at Days 7, 14, 28, 35, and 42
ACPR 42
|
20 percentage of participants
|
10 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 42 days for each armPopulation: Only participants eligible for efficacy analysis were analyzed.
Time to recurrence of either P. vivax or P. falciparum malaria as measured by PCR
Outcome measures
| Measure |
Arm 1 B (Cohort 1)
n=10 Participants
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=9 Participants
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Time to Recurrence of Malaria Infection, PCR Adjusted
|
24.0 days
Standard Deviation 10.1
|
22.8 days
Standard Deviation 9.94
|
Adverse Events
Arm 1 B (Cohort 1)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2 B (Cohort 2)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 B (Cohort 1)
n=10 participants at risk
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 participants at risk
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Infections and infestations
Febrile syndrome of probable viral etiology
|
10.0%
1/10 • Number of events 1 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
0.00%
0/12 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
|
Infections and infestations
Severe Malaria Grade 4
|
0.00%
0/10 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
8.3%
1/12 • Number of events 1 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
Other adverse events
| Measure |
Arm 1 B (Cohort 1)
n=10 participants at risk
Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
Arm 2 B (Cohort 2)
n=12 participants at risk
600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax
(+)-SJ000557733 (SJ733): Anti-Malarial
|
|---|---|---|
|
Gastrointestinal disorders
Food Poisoning
|
10.0%
1/10 • Number of events 1 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
0.00%
0/12 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
|
General disorders
Hepatosplenomegaly
|
10.0%
1/10 • Number of events 1 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
0.00%
0/12 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
|
Renal and urinary disorders
Bilateral nephromegaly
|
10.0%
1/10 • Number of events 1 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
0.00%
0/12 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
|
Hepatobiliary disorders
Alkaline Phosphatase Increase
|
0.00%
0/10 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
8.3%
1/12 • Number of events 1 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pharyngitis
|
0.00%
0/10 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
8.3%
1/12 • Number of events 1 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
|
Endocrine disorders
Increased Glucose
|
0.00%
0/10 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
8.3%
1/12 • Number of events 1 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
|
Infections and infestations
Herpetic gingivostomatitis
|
0.00%
0/10 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
8.3%
1/12 • Number of events 1 • AE data was collected for the 42 days that a participant was enrolled.
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. Signs and symptoms of malaria were not recorded as adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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. 2. 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.
- Publication restrictions are in place
Restriction type: OTHER