Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia
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.
Sponsor: SDK Therapeutics, Inc.
A PHASE1 clinical study on Acute Promyelocytic Leukemia (APL), this trial is completed. The trial is conducted by SDK Therapeutics, Inc. and has accumulated 4 data snapshots since 2025. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Status Flow
Change History
4 versions recorded-
Dec 2025 — Present [monthly]
Completed PHASE1
Phase: PHASE1/PHASE2 → PHASE1
-
Aug 2025 — Dec 2025 [monthly]
Completed PHASE1/PHASE2
Status: Recruiting → Completed
-
Jun 2025 — Aug 2025 [monthly]
Recruiting PHASE1/PHASE2
-
Apr 2025 — Jun 2025 [monthly]
Recruiting PHASE1/PHASE2
First recorded
Mar 2025
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- SDK Therapeutics, Inc.
- The University of Hong Kong
For direct contact, visit the study record on ClinicalTrials.gov .