SDK-001 / SkinDermic - LARVOL DELTA

Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia (clinicaltrials.gov) - P1/2 | N=12 | Completed | Sponsor: SDK Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A RANDOMIZED, OPEN LABEL, SINGLE-DOSE, 4-PERIOD, 4-TREATMENT CROSS-OVER STUDY TO EVALUATE THE PHARMACOKINETICS OF ORAL ARSENIC TRIOXIDE SOLUTION (SDK001) AND TO COMPARE TO INTRAVENOUS ARSENIC TRIOXIDE (EHA 2025) - "Approximately 12 patients will be enrolled in this study and randomized in a 1:1:1:1 ratio to one of the four treatment sequences with a 7-day washout between periods (Table 1). The primary end-points include: AUCinf of AsIII for the comparison of SDK001 versus i.v.-ATO under fasted condition; Cmax and AUCinf of AsIII, for the comparison of SDK001 under fasted condition versus fed condition; Cmax and AUCinf of AsIII, for the comparison of SDK001 with or without calcium product under fasted state.Table 1 Sequence 1 2 3 4 N 3 3 3 3 Period 1 A B C D Period 2 B D A C Period 3 C A D B Period 4 D C B A A: 0.15 mg/kg i.v.-ATO, fasted; B: 0.15 mg/kg SDK001 fasted; C: 0.15 mg/kg SDK001 fed; D: 0.15 mg/kg SDK001 with 1 g calcium carbonate tablet, fasted."

Clinical • PK/PD data • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Leukemia • Oncology • PML

Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia (clinicaltrials.gov) - P1/2 | N=12 | Recruiting | Sponsor: SDK Therapeutics, Inc.

New P1/2 trial • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology