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 participants, SDK Therapeutics, Inc.

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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.

Registry	NCT06882031
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, sequential, masking: none, treatment
Enrollment	12 (Actual)
Sponsor	SDK Therapeutics, Inc. (Industry); collaborators: The University of Hong Kong
Conditions	Acute Promyelocytic Leukemia (APL)
Interventions	Treatment A: Arsenic Trioxide (ATO) Intravenous, Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state, Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state, Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate (Drug)
Dates	start 2025-03-11, primary completion 2025-06-25, completion 2025-06-30, first posted 2025-03-18, last updated 2025-11-18
Locations	1 site in Hong Kong

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Sequence 1	Experimental	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 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
Sequence 2	Experimental	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
Sequence 3	Experimental	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
Sequence 4	Experimental	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

Treatment A: Arsenic Trioxide (ATO) Intravenous (Drug): 0.15 mg/kg 2-hour IV infusion of ATO administered under fasted state in single dose
Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state (Drug): 0.15 mg/kg SDK001 administered orally under fasted state in single dose
Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state (Drug): 0.15 mg/kg SDK001 administered orally under fed state (high fat breakfast) in single dose
Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate (Drug): 0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose

+Outcome measures

Primary outcomes

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 [Over 4 weeks in maintenance cycle]: Primary Endpoints • AUCinf of AsIII (the pharmacologically active species of ATO) for comparison of SDK001 versus IV ATO

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

-Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression

Exclusion Criteria:

* Relapsed or refractory APL

+Locations (1)

Facility	City	Country	Status
The University of Hong Kong-Clinical Trial Centre Phase 1 Centre	Hong Kong	Hong Kong