Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia

NCT06882031 ↗

Phase 1 Completed 12 enrolled SDK Therapeutics, Inc. The University of Hong Kong · collab

RandomizedSequentialOpen-labelTreatment

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

Timeline

Start: 2025-03-11
Primary completion: 2025-06-25
Completion: 2025-06-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Calcium carbonate	Other / unclassified	1 g	Oral
Subject	arsenic trioxide	Small molecule	0.15 mg/kg	Intravenous

Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia

Summary

Timeline

Drugs

Indications