Trial Outcomes & Findings for A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects (NCT NCT00928083)

Last Updated: 2015-01-08

Results Overview

Safety/Tolerability evaluation took into account the recorded AE profile, clinical laboratory safety tests, vital signs, 12 lead and continuous (Parts A and C) ECG monitoring, audiometry/Brainstem Auditory Evoked Potentials (BAEP) parameters (Parts A and C) including any additional tests required to evaluate any safety concerns.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

63 participants

Primary outcome timeframe

From screening and at 10 (+/-2) days after last dose of study medication

Results posted on

2015-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Part A - OZ439 Single Dose - Cohort 1 OZ439 50 mg then 200 mg, then 800 mg, then 1600 mg, then Placebo	Part A - OZ439 Single Dose - Cohort 2 OZ439 50 mg, then 100 mg, then 400 mg, then 1200 mg, then Placebo	Part A - OZ439 Single Dose - Cohort 3 Oral Dispersion OZ439 50-1600 mg	Part B - Food Effect - Cohort 1 Food Effect - Cohort 1 800mg OZ439 Fasted then Fed	Part B - Food Effect - Cohort 2 Food Effect - Cohort 2 800mg OZ439 Fed then Fasted	Part C - 200mg OZ439 Multiple Dose 200mg OZ439 for 3 consecutive days	Part C - 400mg OZ439 Multiple Dose OZ439 400mg for 3 consecutive days	Part C - 800mg OZ439 Multiple Dose OZ439 800mg for 3 consecutive days	Part C - Placebo Part C - Placebo
Overall Study STARTED	10	8	8	6	7	6	6	6	6
Overall Study COMPLETED	6	8	8	5	6	6	6	6	6
Overall Study NOT COMPLETED	4	0	0	1	1	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A - OZ439 Single Rising Dose n=26 Participants Included 3 Cohorts, where subjects in cohorts 1 and 2 were randomized to a treatment sequence, receiving doses of OZ439 on four occasions and placebo on one occasion, and subjects in Cohort 3 were administered increasing doses of the oral dispersion.	Part B - OZ439 Food Effect n=13 Participants Subjects were randomized to sequence groups, "fasted/fed or fed/fasted" while receiving a single dose of 800 mg OZ439.	Part C - OZ439 Multiple Rising Dose n=24 Participants Subjects were assigned to individual dose cohorts (200, 400 and 800 mg OZ439) and placebo.	Total n=63 Participants Total of all reporting groups
Age, Continuous	35.6 years STANDARD_DEVIATION 10.35 • n=5 Participants	33.7 years STANDARD_DEVIATION 8.49 • n=7 Participants	40.1 years STANDARD_DEVIATION 10.17 • n=5 Participants	36.5 years STANDARD_DEVIATION 9.67 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants	40 Participants n=4 Participants
Region of Enrollment United States	26 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants	63 participants n=4 Participants

PRIMARY outcome

Timeframe: From screening and at 10 (+/-2) days after last dose of study medication