A Phase 1 interventional study of Treatment A: Arsenic Trioxide (ATO) Intravenous and Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state in Acute Promyelocytic Leukemia (APL), sponsored by SDK Therapeutics, Inc.. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by SDK Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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
134 studies on the registry are indexed under Leukemia, Promyelocytic, Acute; 16 are open to participants now.
This study's enrollment of 12 is below the median of 51 across 100 interventional studies indexed under Leukemia, Promyelocytic, Acute.
Browse Leukemia, Promyelocytic, Acute studies →SDK Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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-Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this treatment Arm 1, patients will receive one dose of the following interventions one week apart * A: IV Arsenic Trioxide under fasted state * B: SDK001 under fasted state * C: SDK001 under fed state * D: SDK001 with calcium carbonate under fasted state
Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous · Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state · Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state · Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate
In this treatment Arm 2, patients will receive one dose of the following interventions one week apart * B: SDK001 under fasted state * D: SDK001 with calcium carbonate * A: IV Arsenic Trioxide under fasted state * C: SDK001 under fed state
Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous · Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state · Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state · Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate
In this treatment Arm 3, patients will receive one dose of the following interventions one week apart * C: SDK001 under fed state * A: IV Arsenic Trioxide under fasted state * D: SDK001 with calcium carbonate * B: SDK001 under fasted state
Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous · Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state · Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state · Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate
In this treatment Arm 4, patients will receive one dose of the following interventions one week apart * D: SDK001 with calcium carbonate * C: SDK001 under fed state * B: SDK001 under fasted state * A: IV Arsenic Trioxide under fasted state
Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous · Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state · Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state · Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate
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
Drug page: Calcium Carbonate
0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose
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
Ran from Mar 2025 to primary completion in Jun 2025, 3 months.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Arsenic Trioxide · Calcium Carbonate
Leukemia, Promyelocytic, Acute →
SDK Therapeutics, Inc.