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

SDK Therapeutics, Inc.

Status and phase: Completed; Phase 1

Conditions: Acute Promyelocytic Leukemia (APL)

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06882031

SDKARS-101

173343 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 criteria

• Relapsed or refractory APL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

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

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

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

Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous

Sequence 2

Experimental group

Description:

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

Treatment:

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

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

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

Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous

Sequence 3

Experimental group

Description:

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

Treatment:

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

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

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

Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous

Sequence 4

Experimental group

Description:

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

Treatment:

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

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

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

Drug: Treatment A: Arsenic Trioxide (ATO) Intravenous