Trial Outcomes & Findings for Safety, Tolerability & Pharmacokinetics (PK) of Co-administered Single Doses of OZ439 and Mefloquine (MQ) in Healthy Volunteers (NCT NCT01615822)
NCT ID: NCT01615822
Last Updated: 2015-04-16
Results Overview
Area under the plasma concentration versus time curve (AUC) of OZ439
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Up to 42 days post-dose
Results posted on
2015-04-16
Participant Flow
Participant milestones
| Measure |
Cohort 1
Period 1: OZ439 100mg single dose oral suspension
Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
|
Cohort 2
Period 1: OZ439 400mg single dose oral suspension
Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
|
Placebo
Placebo
|
|---|---|---|---|
|
Period 1
STARTED
|
8
|
11
|
6
|
|
Period 1
COMPLETED
|
7
|
9
|
6
|
|
Period 1
NOT COMPLETED
|
1
|
2
|
0
|
|
Period 2
STARTED
|
7
|
9
|
6
|
|
Period 2
COMPLETED
|
7
|
8
|
4
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1
Period 1: OZ439 100mg single dose oral suspension
Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
|
Cohort 2
Period 1: OZ439 400mg single dose oral suspension
Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
|
Placebo
Placebo
|
|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
|
Period 1
Adverse Event
|
1
|
1
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
1
|
2
|
Baseline Characteristics
Safety, Tolerability & Pharmacokinetics (PK) of Co-administered Single Doses of OZ439 and Mefloquine (MQ) in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Cohort 1
n=8 Participants
Period 1: OZ439 100mg single dose oral suspension
Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
|
Cohort 2
n=10 Participants
Period 1: OZ439 400mg single dose oral suspension
Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
|
Placebo
n=6 Participants
Placebo
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
30.6 years
STANDARD_DEVIATION 9.42 • n=7 Participants
|
26 years
STANDARD_DEVIATION 4.45 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 8.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
6 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 42 days post-dosePopulation: Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.
Area under the plasma concentration versus time curve (AUC) of OZ439
Outcome measures
| Measure |
OZ439 100mg Single Dose
n=7 Participants
OZ439 100mg single dose oral suspension
OZ439 100mg: OZ439 100mg oral suspension, single dose
|
OZ439 100mg Plus MQ 250mg Single Doses
n=7 Participants
Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
OZ439 100mg: OZ439 100mg oral suspension, single dose
MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose
|
OZ439 400mg Single Dose
n=9 Participants
OZ439 400mg single dose oral suspension
OZ439 400mg: OZ439 400mg oral suspension, single dose
|
OZ439 400mg Plus MQ 750mg Single Doses
n=9 Participants
Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
OZ439 400mg: OZ439 400mg oral suspension, single dose
MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose
|
|---|---|---|---|---|
|
OZ439 AUC0-t
|
1060 ng*h/mL
Geometric Coefficient of Variation 32
|
1060 ng*h/mL
Geometric Coefficient of Variation 32
|
8100 ng*h/mL
Geometric Coefficient of Variation 30
|
7300 ng*h/mL
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Up to 42 days post-dosePopulation: Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.
Peak Plasma Concentration (Cmax) of OZ439
Outcome measures
| Measure |
OZ439 100mg Single Dose
n=7 Participants
OZ439 100mg single dose oral suspension
OZ439 100mg: OZ439 100mg oral suspension, single dose
|
OZ439 100mg Plus MQ 250mg Single Doses
n=7 Participants
Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
OZ439 100mg: OZ439 100mg oral suspension, single dose
MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose
|
OZ439 400mg Single Dose
n=9 Participants
OZ439 400mg single dose oral suspension
OZ439 400mg: OZ439 400mg oral suspension, single dose
|
OZ439 400mg Plus MQ 750mg Single Doses
n=9 Participants
Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
OZ439 400mg: OZ439 400mg oral suspension, single dose
MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose
|
|---|---|---|---|---|
|
OZ439 Cmax
|
157 ng/mL
Geometric Coefficient of Variation 24
|
147 ng/mL
Geometric Coefficient of Variation 33
|
821 ng/mL
Geometric Coefficient of Variation 21
|
745 ng/mL
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: Up to 42 days post-dosePopulation: Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.
Area under the plasma concentration versus time curve (AUC) of MQ
Outcome measures
| Measure |
OZ439 100mg Single Dose
n=7 Participants
OZ439 100mg single dose oral suspension
OZ439 100mg: OZ439 100mg oral suspension, single dose
|
OZ439 100mg Plus MQ 250mg Single Doses
n=8 Participants
Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
OZ439 100mg: OZ439 100mg oral suspension, single dose
MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose
|
OZ439 400mg Single Dose
OZ439 400mg single dose oral suspension
OZ439 400mg: OZ439 400mg oral suspension, single dose
|
OZ439 400mg Plus MQ 750mg Single Doses
Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
OZ439 400mg: OZ439 400mg oral suspension, single dose
MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose
|
|---|---|---|---|---|
|
MQ AUC0-t
|
167 ng*h/mL
Geometric Coefficient of Variation 18
|
421 ng*h/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 days post-dosePopulation: Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.
Peak Plasma Concentration (Cmax) of MQ
Outcome measures
| Measure |
OZ439 100mg Single Dose
n=7 Participants
OZ439 100mg single dose oral suspension
OZ439 100mg: OZ439 100mg oral suspension, single dose
|
OZ439 100mg Plus MQ 250mg Single Doses
n=8 Participants
Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
OZ439 100mg: OZ439 100mg oral suspension, single dose
MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose
|
OZ439 400mg Single Dose
OZ439 400mg single dose oral suspension
OZ439 400mg: OZ439 400mg oral suspension, single dose
|
OZ439 400mg Plus MQ 750mg Single Doses
Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
OZ439 400mg: OZ439 400mg oral suspension, single dose
MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose
|
|---|---|---|---|---|
|
MQ Cmax
|
0.602 ng/mL
Geometric Coefficient of Variation 27
|
1.34 ng/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=8 participants at risk
Period 1: OZ439 100mg single dose oral suspension
Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
|
Cohort 2
n=10 participants at risk
Period 1: OZ439 400mg single dose oral suspension
Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
|
Placebo
n=6 participants at risk
Placebo
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Gun Shot wound
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
Other adverse events
| Measure |
Cohort 1
n=8 participants at risk
Period 1: OZ439 100mg single dose oral suspension
Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
|
Cohort 2
n=10 participants at risk
Period 1: OZ439 400mg single dose oral suspension
Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
|
Placebo
n=6 participants at risk
Placebo
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
16.7%
1/6 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
General disorders
Medical Device Site Reaction
|
75.0%
6/8 • Number of events 6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
60.0%
6/10 • Number of events 6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
66.7%
4/6 • Number of events 4 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Infections and infestations
Influenza
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Infections and infestations
Laryngitis Viral
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Infections and infestations
Nasopharynigitis
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
20.0%
2/10 • Number of events 2 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Infections and infestations
Tinea Cruris
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Infections and infestations
Viral Tonsilitis
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
16.7%
1/6 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
20.0%
2/10 • Number of events 2 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Psychiatric disorders
Confusional Arousal
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Psychiatric disorders
Depressive Symptom
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Psychiatric disorders
Nightmare
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Skin and subcutaneous tissue disorders
Blister
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Investigations
ECG QT Shortened
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Investigations
GGT Increased
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Eye disorders
Seasonal Conjunctivitis
|
12.5%
1/8 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
10.0%
1/10 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/6 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
0.00%
0/8 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
0.00%
0/10 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
16.7%
1/6 • Number of events 1 • Up to Day 42 post-dose
All subjects who received at least one dose of study drug were included in the safety analysis set. Adverse events were collected irrespective of whether or not the patients had received OZ439 alone or in combination with MQ.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place