Trial Outcomes & Findings for Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers (NCT NCT01383096)

NCT ID: NCT01383096

Last Updated: 2015-01-29

Results Overview

The maximum observed plasma drug concentrations (Cmax)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 52 participants
• Primary outcome timeframe: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing
• Results posted on: 2015-01-29

Participant Flow

The first subject was randomised on 19-Apr-12; The last subject last visit was on 04-Aug-12. Subjects were recruited at the study site, Nucleus Network.

There was no wash-out, run-in or transition period between enrolment and group assignment.

Participant milestones

Measure	Cohort 1 Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.	Cohort 2 Subjects received a single of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.	Cohort 3 Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
First Intervention (8 Days) STARTED	19	17	16
First Intervention (8 Days) COMPLETED	19	17	16
First Intervention (8 Days) NOT COMPLETED	0	0	0
Second Intervention (8 Days) STARTED	19	17	16
Second Intervention (8 Days) COMPLETED	19	16	14
Second Intervention (8 Days) NOT COMPLETED	0	1	2
Third Intervention (8 Days) STARTED	19	16	0
Third Intervention (8 Days) COMPLETED	15	12	0
Third Intervention (8 Days) NOT COMPLETED	4	4	0
Fourth Intervention (8 Days) STARTED	15	12	0
Fourth Intervention (8 Days) COMPLETED	13	12	0
Fourth Intervention (8 Days) NOT COMPLETED	2	0	0
Fifth Intervention (8 Days) STARTED	13	0	0
Fifth Intervention (8 Days) COMPLETED	11	0	0
Fifth Intervention (8 Days) NOT COMPLETED	2	0	0

Reasons for withdrawal

Measure	Cohort 1 Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.	Cohort 2 Subjects received a single of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.	Cohort 3 Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
Second Intervention (8 Days) Vomited Study Drug within 30min of admin	0	0	1
Second Intervention (8 Days) Haemoglobin was <13.5 g/dL	0	1	1
Third Intervention (8 Days) Elevated AST	0	1	0
Third Intervention (8 Days) Vomited Study Drug within 30min of admin	1	3	0
Third Intervention (8 Days) Adverse Event	1	0	0
Third Intervention (8 Days) Withdrawal by Subject	1	0	0
Third Intervention (8 Days) QTcF was greater than 450 msec	1	0	0
Fourth Intervention (8 Days) Haemoglobin was <13.5 g/dL	1	0	0
Fourth Intervention (8 Days) QTcF was greater than 450 msec	1	0	0
Fifth Intervention (8 Days) Withdrawal by Subject	1	0	0
Fifth Intervention (8 Days) haemoglobin was <13.5 g/dL	1	0	0

Baseline Characteristics

Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers

Baseline characteristics by cohort

Measure	Cohort 1 n=19 Participants Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.	Cohort 2 n=17 Participants Subjects received a single dose of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.	Cohort 3 n=16 Participants Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.	Total n=52 Participants Total of all reporting groups
Age, Continuous	29.3 years STANDARD_DEVIATION 6.2 • n=93 Participants	27.2 years STANDARD_DEVIATION 5.7 • n=4 Participants	25.4 years STANDARD_DEVIATION 4.4 • n=27 Participants	27.4 years STANDARD_DEVIATION 5.6 • n=483 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	17 Participants n=4 Participants	16 Participants n=27 Participants	52 Participants n=483 Participants

PRIMARY outcome

Timeframe: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing

Population: Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.

The maximum observed plasma drug concentrations (Cmax)

Outcome measures

Measure	Cohort 1 - Treatment A: OZ439 800mg PIB Fed n=12 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.	Cohort 1 - Treatment B: OZ439 800mg PIB Fasted n=12 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.	Cohort 1 - Treatment:OZ439 800mg PIB With Milk n=12 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.	Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted n=12 Participants OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.	Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk n=12 Participants OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.	Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted n=12 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted	Cohort 2 - Treatment G: OZ439 800mg PIB With Milk n=12 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.	Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted n=12 Participants OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.	Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk n=12 Participants OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.	Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted n=14 Participants OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.	Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted n=14 Participants OZ439 400 mg as prototype solution formulation 1. Administered fasted.
OZ439 Cmax	1910 ng/ml Geometric Coefficient of Variation 32.9	827 ng/ml Geometric Coefficient of Variation 47.7	1930 ng/ml Geometric Coefficient of Variation 27.4	1440 ng/ml Geometric Coefficient of Variation 46.2	1830 ng/ml Geometric Coefficient of Variation 25.9	538 ng/ml Geometric Coefficient of Variation 33.2	1530 ng/ml Geometric Coefficient of Variation 31.2	846 ng/ml Geometric Coefficient of Variation 44.9	1680 ng/ml Geometric Coefficient of Variation 36.2	1160 ng/ml Geometric Coefficient of Variation 35.8	719 ng/ml Geometric Coefficient of Variation 29.0

PRIMARY outcome

Timeframe: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing

Population: Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.

Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)

Outcome measures

Measure	Cohort 1 - Treatment A: OZ439 800mg PIB Fed n=11 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.	Cohort 1 - Treatment B: OZ439 800mg PIB Fasted n=12 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.	Cohort 1 - Treatment:OZ439 800mg PIB With Milk n=11 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.	Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted n=11 Participants OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.	Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk n=11 Participants OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.	Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted n=10 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted	Cohort 2 - Treatment G: OZ439 800mg PIB With Milk n=12 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.	Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted n=12 Participants OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.	Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk n=12 Participants OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.	Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted n=14 Participants OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.	Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted n=14 Participants OZ439 400 mg as prototype solution formulation 1. Administered fasted.
OZ439 AUC0-∞	29200 ng.h/mL Geometric Coefficient of Variation 31.2	10700 ng.h/mL Geometric Coefficient of Variation 52.8	24500 ng.h/mL Geometric Coefficient of Variation 44.0	19000 ng.h/mL Geometric Coefficient of Variation 39.6	25800 ng.h/mL Geometric Coefficient of Variation 26.9	7460 ng.h/mL Geometric Coefficient of Variation 34.1	21600 ng.h/mL Geometric Coefficient of Variation 33.0	11700 ng.h/mL Geometric Coefficient of Variation 54.9	22900 ng.h/mL Geometric Coefficient of Variation 41.9	13800 ng.h/mL Geometric Coefficient of Variation 38.0	7410 ng.h/mL Geometric Coefficient of Variation 33.3

PRIMARY outcome

Timeframe: 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing

Population: Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.

Apparent terminal half life (t1/2)

Outcome measures

Measure	Cohort 1 - Treatment A: OZ439 800mg PIB Fed n=11 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.	Cohort 1 - Treatment B: OZ439 800mg PIB Fasted n=12 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.	Cohort 1 - Treatment:OZ439 800mg PIB With Milk n=11 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.	Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted n=11 Participants OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.	Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk n=11 Participants OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.	Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted n=10 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted	Cohort 2 - Treatment G: OZ439 800mg PIB With Milk n=12 Participants OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.	Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted n=12 Participants OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.	Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk n=12 Participants OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.	Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted n=14 Participants OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.	Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted n=14 Participants OZ439 400 mg as prototype solution formulation 1. Administered fasted.
OZ439 t1/2	83.5 hours Geometric Coefficient of Variation 27.8	82.3 hours Geometric Coefficient of Variation 46.9	70.5 hours Geometric Coefficient of Variation 45.9	90.0 hours Geometric Coefficient of Variation 26.0	79.8 hours Geometric Coefficient of Variation 27.2	84.7 hours Geometric Coefficient of Variation 27.3	79.3 hours Geometric Coefficient of Variation 28.0	85.7 hours Geometric Coefficient of Variation 22.0	70.6 hours Geometric Coefficient of Variation 17.7	63.6 hours Geometric Coefficient of Variation 14.7	91.1 hours Geometric Coefficient of Variation 35.7

Adverse Events

Cohort 1 - Treatment A: OZ439 800mg PIB Fed

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 1 - Treatment B: OZ439 800mg PIB Fasted

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 1 - Treatment C: OZ439 800mg PIB With Milk

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 2 - Treatment G: OZ439 800mg PIB With Milk

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cohort 1 - Treatment A: OZ439 800mg PIB Fed n=17 participants at risk OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.	Cohort 1 - Treatment B: OZ439 800mg PIB Fasted n=14 participants at risk OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.	Cohort 1 - Treatment C: OZ439 800mg PIB With Milk n=15 participants at risk OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.	Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted n=17 participants at risk OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.	Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk n=15 participants at risk OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.	Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted n=13 participants at risk OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.	Cohort 2 - Treatment G: OZ439 800mg PIB With Milk n=15 participants at risk OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.	Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted n=17 participants at risk OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.	Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk n=13 participants at risk OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.	Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted n=14 participants at risk OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.	Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted n=16 participants at risk OZ439 400 mg as prototype solution formulation 1. Administered fasted.
Gastrointestinal disorders Diarrhoea	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	11.8% 2/17 • Number of events 2 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Gastrointestinal disorders Nausea	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	41.2% 7/17 • Number of events 7 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	33.3% 5/15 • Number of events 5 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	15.4% 2/13 • Number of events 2 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	13.3% 2/15 • Number of events 2 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	29.4% 5/17 • Number of events 5 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	30.8% 4/13 • Number of events 4 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	35.7% 5/14 • Number of events 5 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	25.0% 4/16 • Number of events 4 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	11.8% 2/17 • Number of events 2 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	17.6% 3/17 • Number of events 3 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.2% 1/16 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Nervous system disorders Headache	11.8% 2/17 • Number of events 2 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	17.6% 3/17 • Number of events 4 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	26.7% 4/15 • Number of events 4 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	15.4% 2/13 • Number of events 2 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	17.6% 3/17 • Number of events 3 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.7% 1/13 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Gastrointestinal disorders Abdominal Discomfort	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Gastrointestinal disorders Abnormal faeces	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
General disorders Pyrexia	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Infections and infestations Sinusitis	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.7% 1/13 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Injury, poisoning and procedural complications Limb injury	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Injury, poisoning and procedural complications Neck injury	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Investigations Blood pressure orthostatic decreased	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Metabolism and nutrition disorders Gout	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Nervous system disorders Dizziness	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Nervous system disorders Lethargy	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.7% 1/13 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Nervous system disorders Sleep paralysis	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Skin and subcutaneous tissue disorders Hypoaesthesia facial	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.1% 1/14 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	7.7% 1/13 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Vascular disorders Phlebitis superficial	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	6.7% 1/15 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Eye disorders Photophobia	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	13.3% 2/15 • Number of events 2 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/17 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/15 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	5.9% 1/17 • Number of events 1 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/13 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/14 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.	0.00% 0/16 • Adverse event monitoring throughout the admission period. The Safety population was comprised of all randomised subjects who received any amount of study drug.

Additional Information

Peter Hodsman

Nucleus Network

Phone: + 613 9076 8900

Email: businessdevelopment@nucleusnetwork.com.au

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60