NCT06882031

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: SDK Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Promyelocytic Leukemia (APL)

Interventions

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

Timeline

• Start date: 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 across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study