NCT06882031已完成1 期
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) Under Fasting and Fed Conditions, to Compare to Intravenous Arsenic Trioxide, and to Evaluate Interaction With Calcium Carbonate in Patients With Acute Promyelocytic Leukemia.
SDK Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年3月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of APL characterized by the presence of the t(15;17) translocation or promyelocytic leukemia/retinoic acid receptor alpha gene expression
排除标准
- •Relapsed or refractory APL
结局指标
主要结局
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
时间窗: Over 4 weeks in maintenance cycle
Primary Endpoints • AUCinf of AsIII (the pharmacologically active species of ATO) for comparison of SDK001 versus IV ATO
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
1 期
A Study to Assess the Pharmacokinetic (PK) Properties of Sativex® in Patients With Advanced CancerAdvanced CancerNCT02432612GW Pharmaceuticals Ltd
招募中
1 期
MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid TumorsAdvanced Solid TumorNCT06170294Peking University20
已完成
1 期
A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941Liver DiseaseNCT01187186Astellas Pharma Inc16
已完成
1 期
Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy SubjectsHepatic InsufficiencyNCT01860326Debiopharm International SA32
招募中
不适用
An Open-label Single-arm Pharmacokinetic Trial, Investigating the Effect of CYP3A4 inhibitor Ritonavir on the Pharmacokinetics of Erlotinib (N19RER)NL-OMON22639The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AVL)10