Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia
NCT ID: NCT06882031
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2025-03-11
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Sequence 1
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
Treatment A: Arsenic Trioxide (ATO) Intravenous
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
0.15 mg/kg SDK001 administered orally under fasted state in single dose
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
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
Sequence 2
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
Treatment A: Arsenic Trioxide (ATO) Intravenous
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
0.15 mg/kg SDK001 administered orally under fasted state in single dose
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
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
Sequence 3
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
Treatment A: Arsenic Trioxide (ATO) Intravenous
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
0.15 mg/kg SDK001 administered orally under fasted state in single dose
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
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
Sequence 4
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
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
0.15 mg/kg SDK001 administered orally under fasted state in single dose
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
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
Interventions
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Treatment A: Arsenic Trioxide (ATO) Intravenous
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
0.15 mg/kg SDK001 administered orally under fasted state in single dose
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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
SDK Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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The University of Hong Kong-Clinical Trial Centre Phase 1 Centre
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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173343
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SDKARS-101
Identifier Type: -
Identifier Source: org_study_id
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