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

Last updated: November 14, 2025
Sponsor: SDK Therapeutics, Inc.
Overall Status: Completed

Phase

1

Condition

Leukemia

Treatment

Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate

Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state

Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state

Clinical Study ID

NCT06882031
SDKARS-101
173343
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Relapsed or refractory APL

Study Design

Total Participants: 12
Treatment Group(s): 4
Primary Treatment: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate
Phase: 1
Study Start date:
March 11, 2025
Estimated Completion Date:
June 30, 2025

Connect with a study center

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

    Hong Kong,
    Hong Kong

    Site Not Available

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

    Hong Kong 1819729,
    Hong Kong

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.