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

NCT06882031 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-18

No results posted yet for this 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

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

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER

  • SDK Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2025-06-25
Completion
2025-06-30
FDA Drug
Yes

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06882031 on ClinicalTrials.gov