Trial Outcomes & Findings for A Dose-escalation Study to Investigate Safety and Toleration of OZ439 (NCT NCT01713608)
NCT ID: NCT01713608
Last Updated: 2015-03-23
Results Overview
OZ439 maximum measured plasma concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
Results posted on
2015-03-23
Participant Flow
Participant milestones
| Measure |
OZ439 300mg
300mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 600mg
600mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 700mg
700mg OZ439 drinking solution administered once daily for 3 days with milk
|
Placebo
Placebo to match OZ439 PIB for oral suspension
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
8
|
12
|
|
Overall Study
COMPLETED
|
8
|
6
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose-escalation Study to Investigate Safety and Toleration of OZ439
Baseline characteristics by cohort
| Measure |
OZ439 300mg
n=8 Participants
300mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 600mg
n=6 Participants
600mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 700mg
n=8 Participants
700mg OZ439 drinking solution administered once daily for 3 days with milk
|
Placebo
n=12 Participants
Placebo to match OZ439 PIB for oral suspension
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 8.91 • n=5 Participants
|
25.5 years
STANDARD_DEVIATION 3.39 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 8.09 • n=5 Participants
|
30.5 years
STANDARD_DEVIATION 7.24 • n=4 Participants
|
30.3 years
STANDARD_DEVIATION 7.51 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
12 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Body Mass Index
|
23.1 kg/m2
STANDARD_DEVIATION 2.99 • n=5 Participants
|
22.4 kg/m2
STANDARD_DEVIATION 3.29 • n=7 Participants
|
24.4 kg/m2
STANDARD_DEVIATION 2.78 • n=5 Participants
|
24.2 kg/m2
STANDARD_DEVIATION 3.02 • n=4 Participants
|
23.7 kg/m2
STANDARD_DEVIATION 2.97 • n=21 Participants
|
PRIMARY outcome
Timeframe: Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.Population: PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.
OZ439 maximum measured plasma concentration
Outcome measures
| Measure |
OZ439 300mg
n=8 Participants
300mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 600mg
n=6 Participants
600mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 700mg
n=8 Participants
700mg OZ439 drinking solution administered once daily for 3 days with milk
|
|---|---|---|---|
|
OZ439 Cmax
|
672 ng/mL
Standard Deviation 183
|
1720 ng/mL
Standard Deviation 544
|
1870 ng/mL
Standard Deviation 600
|
PRIMARY outcome
Timeframe: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.Population: PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.
OZ439 Area under the plasma concentration vs time curve from time zero to the time of the last quantifiable concentration t calculated using a log-linear trapezoidal method
Outcome measures
| Measure |
OZ439 300mg
n=8 Participants
300mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 600mg
n=6 Participants
600mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 700mg
n=8 Participants
700mg OZ439 drinking solution administered once daily for 3 days with milk
|
|---|---|---|---|
|
OZ439 AUCτ
|
5970 ng*h/mL
Standard Deviation 1340
|
16500 ng*h/mL
Standard Deviation 5630
|
21300 ng*h/mL
Standard Deviation 6250
|
SECONDARY outcome
Timeframe: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.Population: PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.
Time to reach maximum measured OZ439 plasma concentration
Outcome measures
| Measure |
OZ439 300mg
n=8 Participants
300mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 600mg
n=6 Participants
600mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 700mg
n=8 Participants
700mg OZ439 drinking solution administered once daily for 3 days with milk
|
|---|---|---|---|
|
OZ439 Tmax
|
3.26 hours
Standard Deviation 1.04
|
3.67 hours
Standard Deviation 0.816
|
4.00 hours
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.Population: PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.
OZ439 estimated terminal phase half life
Outcome measures
| Measure |
OZ439 300mg
n=8 Participants
300mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 600mg
n=6 Participants
600mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 700mg
n=8 Participants
700mg OZ439 drinking solution administered once daily for 3 days with milk
|
|---|---|---|---|
|
OZ439 t½
|
122 hours
Standard Deviation 36.2
|
130 hours
Standard Deviation 21.8
|
134 hours
Standard Deviation 44.5
|
Adverse Events
OZ439 300mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OZ439 600mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OZ439 700mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OZ439 300mg
n=8 participants at risk
300mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 600mg
n=6 participants at risk
600mg OZ439 drinking solution administered once daily for 3 days with milk
|
OZ439 700mg
n=8 participants at risk
700mg OZ439 drinking solution administered once daily for 3 days with milk
|
Placebo
n=12 participants at risk
Placebo to match OZ439 PIB for oral suspension
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
8.3%
1/12 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Nervous system disorders
Headache
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
8.3%
1/12 • Number of events 2
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Nervous system disorders
Migraine
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/12
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/12
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
2/8 • Number of events 2
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
8.3%
1/12 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
16.7%
1/6 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
8.3%
1/12 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
16.7%
1/6 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
50.0%
4/8 • Number of events 4
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/12
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
8.3%
1/12 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/12
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/12
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/12
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
8.3%
1/12 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
8.3%
1/12 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/12
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
8.3%
1/12 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
|
General disorders
Influenza like illness
|
0.00%
0/8
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/6
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
12.5%
1/8 • Number of events 1
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
0.00%
0/12
The safety analysis included all 34 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place