Trial Outcomes & Findings for Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection (NCT NCT01213966)
NCT ID: NCT01213966
Last Updated: 2014-12-03
Results Overview
PRR24 is the log10 change in parasitemia over 24 hours estimated from a regression model fit separately for each patient. The relationship between parasite counts and time was analyzed by fitting a variable lag phase, then a linear decline to the natural log of parasite count versus time relationship. The slope of this log linear relationship is the primary end-point. The time points chosen for the regression are those that yield the highest degree of significance when assessing the regression when the number of time points are greater than or equal to 3. No extrapolation was performed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
24 hours after study drug administration
Results posted on
2014-12-03
Participant Flow
Patients were recruited at two study centres in Thailand Primary study centre: Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand Sub-centre: Shoklo Malaria Research Unit, Mae Sod, Tak, Thailand The first patient was enrolled on 24 October 2010 and the last patient completed on 25 May 2012.
There was no washout, run-in or transition following enrolment but prior to group assignment.
Participant milestones
| Measure |
800 mg OZ439 po Single Dose
Cohort 1 received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients was made following a study cohort review
|
400 mg OZ439 p.o. Single Dose
Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
|
200mg OZ439 p.o. Single Dose
Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
|
1200 mg OZ439 po Single Dose
Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.received single dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
21
|
|
Overall Study
COMPLETED
|
19
|
20
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
800 mg OZ439 po Single Dose
Cohort 1 received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients was made following a study cohort review
|
400 mg OZ439 p.o. Single Dose
Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
|
200mg OZ439 p.o. Single Dose
Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
|
1200 mg OZ439 po Single Dose
Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.received single dose
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
3
|
1
|
Baseline Characteristics
Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection
Baseline characteristics by cohort
| Measure |
Cohort 1 - OZ439 800mg
n=20 Participants
800 mg OZ439 po single dose
|
Cohort 2 - OZ439 400mg
n=21 Participants
400 mg OZ439 p.o. single dose
|
Cohort 3 - OZ439 200mg
n=20 Participants
200mg OZ439 p.o. single dose
|
Cohort 4 - OZ439 1200mg
n=21 Participants
1200 mg OZ439 po single dose
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 8.37 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 9.82 • n=7 Participants
|
26.7 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
29.3 years
STANDARD_DEVIATION 8.19 • n=4 Participants
|
28.1 years
STANDARD_DEVIATION 8.97 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Region of Enrollment
Thailand
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
20 participants
n=5 Participants
|
21 participants
n=4 Participants
|
82 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 hours after study drug administrationPRR24 is the log10 change in parasitemia over 24 hours estimated from a regression model fit separately for each patient. The relationship between parasite counts and time was analyzed by fitting a variable lag phase, then a linear decline to the natural log of parasite count versus time relationship. The slope of this log linear relationship is the primary end-point. The time points chosen for the regression are those that yield the highest degree of significance when assessing the regression when the number of time points are greater than or equal to 3. No extrapolation was performed.
Outcome measures
| Measure |
800 mg OZ439 po Single Dose
n=19 Participants
The first cohort received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients with either P. falciparum or P. vivax malaria, was made following a study cohort review of the safety data, drug exposure levels, and the PRR over 24 hours after the investigational product administration (PRR24) obtained from the previous cohort.
|
400 mg OZ439 p.o. Single Dose
n=20 Participants
After review of the data from Cohort 1 (800 mg), patients in Cohort 2 received a single dose of 400 mg OZ439.
|
200mg OZ439 p.o. Single Dose
n=17 Participants
Ultimately, after review of the data from Cohort 1 (800 mg) and data from Cohort 2 (400 mg), patients in Cohort 3 received a single dose of 200 mg OZ439.
|
1200 mg OZ439 po Single Dose
n=20 Participants
Ultimately, after review of the data from Cohort 1 (800 mg), from Cohort 2 (400 mg), and Cohort 3 (200 mg), patients in Cohort 4 received a single dose of 1200 mg OZ439.
It was decided not to proceed with a fifth cohort and no further patients were enrolled.
|
|---|---|---|---|---|
|
Derived Parasite Reduction Rate at 24 Hours (PPR24)
PPR24 Plasmodium Falciparum
|
1.38 Log10 parasites/24h
Interval 0.62 to 2.79
|
1.56 Log10 parasites/24h
Interval 1.29 to 3.11
|
1.71 Log10 parasites/24h
Interval -1.69 to 1.88
|
1.63 Log10 parasites/24h
Interval 1.13 to 3.58
|
|
Derived Parasite Reduction Rate at 24 Hours (PPR24)
PPR24 Plasmodium Vivax
|
2.05 Log10 parasites/24h
Interval 1.46 to 2.79
|
2.18 Log10 parasites/24h
Interval 0.99 to 3.59
|
2.40 Log10 parasites/24h
Interval 1.74 to 3.59
|
1.96 Log10 parasites/24h
Interval 1.86 to 3.09
|
Adverse Events
Cohort 1 - OZ439 800mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 - OZ439 400mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3 - OZ439 200mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 4 - OZ439 1200mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - OZ439 800mg
n=20 participants at risk
800 mg OZ439 po single dose
|
Cohort 2 - OZ439 400mg
n=20 participants at risk
400 mg OZ439 p.o. single dose
|
Cohort 3 - OZ439 200mg
n=20 participants at risk
200mg OZ439 p.o. single dose
|
Cohort 4 - OZ439 1200mg
n=21 participants at risk
1200 mg OZ439 po single dose
|
|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
4.8%
1/21 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Infections and infestations
Malaria relapse
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
Other adverse events
| Measure |
Cohort 1 - OZ439 800mg
n=20 participants at risk
800 mg OZ439 po single dose
|
Cohort 2 - OZ439 400mg
n=20 participants at risk
400 mg OZ439 p.o. single dose
|
Cohort 3 - OZ439 200mg
n=20 participants at risk
200mg OZ439 p.o. single dose
|
Cohort 4 - OZ439 1200mg
n=21 participants at risk
1200 mg OZ439 po single dose
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
4.8%
1/21 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Cardiac disorders
Bundle branch block right
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
4.8%
1/21 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
4.8%
1/21 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Investigations
Blood Creatine PK Increased
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
25.0%
5/20 • Number of events 5 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
4.8%
1/21 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
10.0%
2/20 • Number of events 2 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
4.8%
1/21 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
9.5%
2/21 • Number of events 2 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Investigations
ALAT Increased
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
10.0%
2/20 • Number of events 2 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Investigations
ASAT Increased
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Investigations
ECG QT Prolonged
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
4.8%
1/21 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Investigations
ECG T Wave Abnormal
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Investigations
Heamoglobin decreased
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
10.0%
2/20 • Number of events 2 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
4.8%
1/21 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
9.5%
2/21 • Number of events 2 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
5.0%
1/20 • Number of events 1 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/20 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
0.00%
0/21 • Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
|
Additional Information
Professor Sasithon Pukrittayakamee
Faculty of Tropical Medicine
Phone: (662) 354-9400-19
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60