Status:
COMPLETED
Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia
Lead Sponsor:
SDK Therapeutics, Inc.
Collaborating Sponsors:
The University of Hong Kong
Conditions:
Acute Promyelocytic Leukemia (APL)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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
Eligibility Criteria
Inclusion
- Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression
Exclusion
- Relapsed or refractory APL
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06882031
Start Date
March 11 2025
End Date
June 30 2025
Last Update
November 18 2025
Active Locations (1)
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1
The University of Hong Kong-Clinical Trial Centre Phase 1 Centre
Hong Kong, Hong Kong