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Clinical trial

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.

NCT06882031 is registered in ClinicalTrials.gov with SDK Therapeutics, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

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.
Lead sponsor
SDK Therapeutics, Inc.
Phase
Phase 1
Overall status
Completed
Start date
March 11, 2025
Completion date
June 30, 2025
Enrollment
12 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

acute promyelocytic leukemia (apl)