The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after administration as a tablet formulation in healthy male and female participants.
This is a randomized, placebo-controlled, double blinded, single center phase I bioavailability study with two Single Dose cohorts and one Multiple Doses cohort in a total of 30 healthy male and female healthy volunteers (10 per cohort).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Oxfendazole is a benzimidazole anthelminthic drug.
The placebo tablet is made using the same non-active ingredients and matches the investigational tablet.
Ifakara Health Institute
Bagamoyo, Tanzania
Area under the plasma concentration curve from time zero to the last quantifiable concentration at time t (AUC0-t) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For single dose arms
Time frame: At different time points from pre-dose up to 48 hours after single dose administration
Area under the plasma concentration curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For single dose arms
Time frame: At different time points from pre-dose up to 48 hours after single dose administration
Maximum observed concentration (Cmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For single dose arms
Time frame: At different time points from pre-dose up to 48 hours after single dose administration
Time to maximum observed concentration (Tmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For single dose arms
Time frame: At different time points from pre-dose up to 48 hours after single dose administration
Elimination half-life (t1/2) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For single dose arms
Time frame: At different time points from pre-dose up to 48 hours after single dose administration
Area under the plasma concentration curve over dosing interval (AUCtau) of oxfendazole and its metabolites fenbendazole
For multiple doses arm
Time frame: At different time points from pre-dose up to 72 hours after last dose administration
Accumulation Ratio (Racc) of oxfendazole and its metabolites fenbendazole
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For multiple doses arm
Time frame: At different time points from pre-dose up to 72 hours after last dose administration
Maximum observed concentration (Cmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For multiple doses arm
Time frame: At different time points from pre-dose up to 72 hours after last dose administration
Time to maximum observed concentration (Tmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For multiple doses arm
Time frame: At different time points from pre-dose up to 72 hours after last dose administration
Elimination half-life (t1/2) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For multiple doses arm
Time frame: At different time points from pre-dose up to 72 hours after last dose administration
Safety and tolerability of oxfendazole as measured by number of participants with treatment related adverse events and serious adverse events
Number of participants with treatment related adverse events and serious adverse events
Time frame: From Day 1 to Day 14.
Safety and tolerability of oxfendazole as measured by number of participants with physical examination findings
Number of participants with physical examination findings. Standard examination done on skin, lymph nodes, head, eyes, ears, nose, throat, respiratory, cardiovascular, abdomen, extremities, musculoskeletal, and neurological.
Time frame: At different time points from baseline to Day 14
Safety and tolerability of oxfendazole as measured by number of participants with vital signs findings
Number of participants with vital signs findings (heart rate, blood pressure, axillar temperature, respiratory rate,)
Time frame: At different time points from baseline to Day 14
Safety and tolerability of oxfendazole as measured by number of participants with clinical laboratory test findings
Number of participants with relevant abnormal clinical laboratory tests results (hematology (hemoglobin, white blood cells (differentiation of eosinophils and neutrophils) and platelets), coagulation (prothrombin time and activated partial thromboplastin time), biochemistry (Creatinine, Alanine aminotransferase, Aspartate aminotransferase, total bilirubin, sodium, potassium, chloride, bicarbonate, blood urea nitrogen), urinalysis (proteinuria and glucose))
Time frame: At different time points from baseline to Day 14
Safety and tolerability of oxfendazole as measured by number of participants with 12-lead ECG findings Safety and tolerability of oxfendazole as measured by the change in ECG parameters
Number of participants with 12-lead ECG findings (heart rate (HR), PR interval, QRS, QT, QTcB, QTcF, cardiac rhythm and T wave morphology)
Time frame: Pre-dose, 1 and 2 hours after single dose administration on Day 1; Pre-dose, 1 and 2 hours after dose administration on Day 1 and pre-dose, 1 and 2 hours after dose administration on Day 5 (last dose) for multiple doses administration arm.