CompletedPhase 1

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

Hong Kong12 participantsStarted 2025-03-11

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: Over 4 weeks in maintenance cycle

Trial details

NCT IDNCT06882031

SponsorSDK Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-25

View on ClinicalTrials.gov More Acute Promyelocytic Leukemia (APL) trials