Clinical trial · Interventional
Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia
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.
NCT06882031CI-TRIAL-00097447completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Promyelocytic Leukemia (APL) | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment A: Arsenic Trioxide (ATO) Intravenous | Drug | — | UNRESOLVED |
| Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state | Drug | — | UNRESOLVED |
| Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state | Drug | — | UNRESOLVED |
| Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Sequence 1
- description
- 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
- interventionNames
- Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous
- Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state
- Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state
- Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate
- type
- EXPERIMENTAL
- label
- Sequence 2
- description
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.