Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia
November 14, 2025 updated by: SDK Therapeutics, Inc.
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.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- The University of Hong Kong-Clinical Trial Centre Phase 1 Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sequence 1
In this treatment Arm 1, patients will receive one dose of the following interventions one week apart
|
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
0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose
|
|
Experimental: Sequence 2
In this treatment Arm 2, patients will receive one dose of the following interventions one week apart
|
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
0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose
|
|
Experimental: Sequence 3
In this treatment Arm 3, patients will receive one dose of the following interventions one week apart
|
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
0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose
|
|
Experimental: Sequence 4
In this treatment Arm 4, patients will receive one dose of the following interventions one week apart
|
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
0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: Over 4 weeks in maintenance cycle
|
Primary Endpoints • AUCinf of AsIII (the pharmacologically active species of ATO) for comparison of SDK001 versus IV ATO |
Over 4 weeks in maintenance cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2025
Primary Completion (Actual)
June 25, 2025
Study Completion (Actual)
June 30, 2025
Study Registration Dates
First Submitted
January 23, 2025
First Submitted That Met QC Criteria
March 14, 2025
First Posted (Actual)
March 18, 2025
Study Record Updates
Last Update Posted (Actual)
November 18, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDKARS-101
- 173343 (Other Grant/Funding Number: SDK Therapeutics, Inc.)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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