Acute Promyelocytic Leukemia (APL)
Conditions
Keywords
APL
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
Interventions
DRUGTreatment A: Arsenic Trioxide (ATO) Intravenous
0.15 mg/kg 2-hour IV infusion of ATO administered under fasted state in single dose
DRUGTreatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state
0.15 mg/kg SDK001 administered orally under fasted state in single dose
DRUGTreatment 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
DRUGTreatment 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
Sponsors
The University of Hong Kong
SDK Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hong Kong
Outcome results
None listed