clinical trial · NCT06882031
Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia
SDK Therapeutics, Inc.·phase1·completed·n = 12
Acute Promyelocytic Leukemia (APL)Treatment A: Arsenic Trioxide (ATO) IntravenousTreatment B: SDK001 (Arsenic Trioxide Oral solution) under faster stateTreatment C: SDK001 (Arsenic Trioxide Oral solution) under fed stateTreatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate
brief summary
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
started
Mar 11, 2025
primary completion
Jun 25, 2025
completion
Jun 30, 2025
last updated
Nov 18, 2025
official title
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) Under Fasting and Fed Conditions, to Compare to Intravenous Arsenic Trioxide, and to Evaluate Interaction With Calcium Carbonate in Patients With Acute Promyelocytic Leukemia.
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