Randomized, Open-Label Study to evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) under Fasting and Fed Conditions, to Compare to IV Arsenic Trioxide
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
0.15 mg/kg 2-hour IV infusion of ATO administered under fasted state in single dose
0.15 mg/kg SDK001 administered orally under fasted state in single dose
0.15 mg/kg SDK001 administered orally under fed state (high fat breakfast) in single dose
The University of Hong Kong-Clinical Trial Centre Phase 1 Centre
Hong Kong, Hong Kong
A Randomized, Open Label, Single-Centre, Single-Dose, 4-Period, 4-Treatment Cross-over Study to Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution (SDK001) to Intravenous Arsenic Trioxide
Primary Endpoints • AUCinf of AsIII (the pharmacologically active species of ATO) for comparison of SDK001 versus IV ATO
Time frame: Over 4 weeks in maintenance cycle
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0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose