A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the experimental anti-malarial product, OZ439.
This was a single center study using blood stage Plasmodium falciparum challenge inoculum to characterize the effectiveness of OZ439 against early blood stage Plasmodium Falciparum infection. The study was conducted in three cohorts (n=8) using different doses of OZ439. Dose escalation took place after review of the observed OZ439 safety and pharmacodynamic outcome for the previous cohort by the Safety Review Team. Single doses of 100 mg, 200 mg and 500 mg were administered orally to participants in Cohort 1, Cohort 2 and Cohort 3 respectively.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
OZ439 Powder for Oral Suspension
Q-Pharm
Herston, Queensland, Australia
Individual Parasite Reduction Ratio (PRR)
PRR estimates the efficacy of an anti-malarial treatment and is the ratio of the parasite density between admission and 48 hours post-treatment. Individual subject PRR and corresponding 95% CI were calculated using the slope and corresponding standard error of mean (SE) of the optimal regression model.
Time frame: 48 hours
500mg Cohort Mean Parasite Reduction Ratio (PRR)
OZ439 500mg individual subject PRR and corresponding 95% CI were used to calculate the OZ439 500mg cohort specific PRR and the corresponding 95% CI: the weighted average slope estimate and corresponding SE were calculated by the inverse-variance method.
Time frame: 48 hours
OZ439 Cmax
OZ439 Maximum concentration (Cmax)
Time frame: Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
OZ439 AUC(0-144)
OZ439 Area under the curve to 144 hours
Time frame: Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose
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