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

NCT06882031 | Completed Phase 1 FDA Drug

• 2 other identifiers: SDKARS-101173343
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

APL

Outcome Measures

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

  Primary Endpoints • AUCinf of AsIII (the pharmacologically active species of ATO) for comparison of SDK001 versus IV ATO

  Over 4 weeks in maintenance cycle

Study Arms (4)

Sequence 1

EXPERIMENTAL

In this treatment Arm 1, patients will receive one dose of the following interventions one week apart * A: IV Arsenic Trioxide under fasted state * B: SDK001 under fasted state * C: SDK001 under fed state * D: SDK001 with calcium carbonate under fasted state

Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous; Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state; Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state; Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate

Sequence 2

EXPERIMENTAL

In this treatment Arm 2, patients will receive one dose of the following interventions one week apart * B: SDK001 under fasted state * D: SDK001 with calcium carbonate * A: IV Arsenic Trioxide under fasted state * C: SDK001 under fed state

Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous; Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state; Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state; Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate

Sequence 3

EXPERIMENTAL

In this treatment Arm 3, patients will receive one dose of the following interventions one week apart * C: SDK001 under fed state * A: IV Arsenic Trioxide under fasted state * D: SDK001 with calcium carbonate * B: SDK001 under fasted state

Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous; Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state; Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state; Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate

Sequence 4

EXPERIMENTAL

In this treatment Arm 4, patients will receive one dose of the following interventions one week apart * D: SDK001 with calcium carbonate * C: SDK001 under fed state * B: SDK001 under fasted state * A: IV Arsenic Trioxide under fasted state

Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous; Drug: Treatment B: SDK001 (Arsenic Trioxide Oral solution) under faster state; Drug: Treatment C: SDK001 (Arsenic Trioxide Oral solution) under fed state; Drug: Treatment D: SDK001 (Arsenic Trioxide Oral solution) with calcium carbonate

Interventions

Treatment A: Arsenic Trioxide (ATO) Intravenous DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4

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

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression

You may not qualify if:

• Relapsed or refractory APL

Sponsors & Collaborators

• SDK Therapeutics, Inc.: lead
• The University of Hong Kong: collaborator

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 18, 2025
• Study Start: March 11, 2025
• Primary Completion: June 25, 2025
• Study Completion: June 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-07

Locations

HK (1)