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OpenTrials
Completed

NCT Number: NCT06882031

Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in 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

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Key information

Conditions

Acute Promyelocytic Leukemia (APL) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Hong Kong-Clinical Trial Centre Phase 1 Centre

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment A: Arsenic Trioxide (ATO) Intravenous

Drug

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

Drug

0.15 mg/kg SDK001 administered orally under fasted state in single dose

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

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

SDK Therapeutics, Inc.

Industry

Collaborators

  • The University of Hong Kong

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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