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| ID | Type | Description | Link |
|---|---|---|---|
| 173343 | Other Grant/Funding Number | SDK Therapeutics, Inc. |
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| Name | Class |
|---|---|
| The University of Hong Kong | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | In this treatment Arm 1, patients will receive one dose of the following interventions one week apart
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| Sequence 2 | Experimental | In this treatment Arm 2, patients will receive one dose of the following interventions one week apart
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| Sequence 3 | Experimental | In this treatment Arm 3, patients will receive one dose of the following interventions one week apart
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: Arsenic Trioxide (ATO) Intravenous | Drug | 0.15 mg/kg 2-hour IV infusion of ATO administered under fasted state in single dose |
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| 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 | Primary Endpoints • AUCinf of AsIII (the pharmacologically active species of ATO) for comparison of SDK001 versus IV ATO | Over 4 weeks in maintenance cycle |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong-Clinical Trial Centre Phase 1 Centre | Hong Kong | Hong Kong |
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| Sequence 4 | Experimental | In this treatment Arm 4, patients will receive one dose of the following interventions one week apart
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| Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state | Drug | 0.15 mg/kg SDK001 administered orally under fasted state in single dose |
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| Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state | Drug | 0.15 mg/kg SDK001 administered orally under fed state (high fat breakfast) in single dose |
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| Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate | Drug | 0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose |
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| ID | Term |
|---|---|
| D015473 | Leukemia, Promyelocytic, Acute |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077237 | Arsenic Trioxide |
| ID | Term |
|---|---|
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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