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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

March 11, 2025

Primary Completion Date

June 25, 2025

Study Completion Date

June 30, 2025

Conditions
Acute Promyelocytic Leukemia (APL)
Interventions
DRUG

Treatment A: Arsenic Trioxide (ATO) Intravenous

0.15 mg/kg 2-hour IV infusion of ATO administered under fasted state in single dose

DRUG

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

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

DRUG

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

0.15 mg/kg SDK001 administered orally under fed state (high fat breakfast) in single dose

DRUG

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

0.15 mg/kg SDK001 administered orally with calcium carbonate in tablet form (1g) under fasted state in single dose

Trial Locations (1)

Unknown

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

All Listed Sponsors
collaborator

The University of Hong Kong

OTHER

lead

SDK Therapeutics, Inc.

INDUSTRY

NCT06882031 - Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia | Biotech Hunter | Biotech Hunter