NCT07444268尚未招募1 期
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of DSP-5336 Following a Single Oral Dose in Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Myeloproliferative Neoplasms
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Total recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336
研究概览
简要总结
The purpose of this study is to evaluate the absorption, metabolism, and excretion of DSP-5336 following a single oral administration of the study drug in patients with hematologic malignancies whose disease has progressed after available standard therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female, of any race, ≥ 18 years of age. Female patients must be surgically sterile or postmenopausal. Male patients must be permanently sterile or agree to use contraception.
- •Have an advanced hematological malignancy that is relapsed, refractory, or has progressed following receipt of standard and available treatments.
- •Any prior pre-treatment toxicities resolved to ≤Grade 1 prior to enrolment, with exception of ≤Grade 2 alopecia or neuropathy.
- •Adequate kidney and liver function
- •ECOG performance status of ≤
- •Able to attend the required study visits, including the confinement period for monitoring and collection of bowel movements and micturition.
- •Able to comprehend and are willing to sign the ICF and abide by the study restrictions.
排除标准
- •Histologic diagnosis of acute promyelocytic leukemia.
- •Abnormal ECG that is clinically significant, such as QTcF > 480 msec. QT interval correction can be performed in the case of bundle branch block.
- •History of torsades de pointes.
- •Left ventricular ejection fraction ≤ 45%, as determined by echocardiogram.
- •Have any concurrent conditions that could pose an undue risk or interfere with interpretation of the study results, including, but not limited to clinically significant non-healing or healing wounds, concurrent congestive heart failure, unstable angina, cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation), myocardial infarction within 6 months, acute coronary syndrome within 6 months, significant pulmonary disease (shortness of breath at rest or on mild exertion; eg, due to concurrent severe obstructive pulmonary disease, hypertension not controlled with concomitant medication, or diabetes mellitus with > 2 episodes of ketoacidosis in the prior 6 months).
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
- •History or evidence of severe dysphagia, short-gut syndrome, gastroparesis, gastrointestinal tract disease, malabsorption syndrome, the requirement for intravenous alimentation, gastric/jejunal feeds, any uncontrolled gastrointestinal disease, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally, including the inability to swallow oral medication
- •Have cognitive, psychological, or psychosocial impediment that would impair their ability to receive therapy according to the protocol or would adversely affect their ability to comply with the informed consent process, protocol, or protocol-required visits and procedures.
- •History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of check-in, unless approved by the investigator and medical monitor.
- •Active and uncontrolled bacterial, viral, or fungal infection requiring parenteral therapy.
- •Positive hepatitis panel and/or positive human immunodeficiency virus test indicative of active infection. Patients whose results are compatible with prior immunization may be included.
- •Undergone HSCT, chimeric antigen receptor cell therapy, or other modified T-cell therapy within 60 days prior to dosing.
- •Received donor lymphocyte infusion within 28 days prior to dosing, receiving immunosuppressive therapy post-HSCT, or have clinically active GVHD or GVHD requiring active medical intervention other than the use of topical steroids for ongoing cutaneous GVHD.
- •Received systemic calcineurin inhibitors within 2 weeks prior to dosing.
- •Received other anticancer drugs or other investigational treatment within 14 days or 5 half-lives, whichever is shorter, prior to dosing.
- •Major surgery within 28 days prior to dosing.
- •Any known intolerance or hypersensitivity to components of the study intervention.
- •Patients who have previously been dosed in > 2 radiolabeled drug studies in the last 12 months. For patients who have previously been dosed in ≤ 2 radiolabeled drug studies within the last 12 months, the previous radiolabeled dose must be at least 4 months prior to check-in to the study site where exposures are known to the investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the investigator.
- •Poor peripheral venous access.
- •Patients with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- •Patients who, in the opinion of the investigator or designee, should not participate in this study.
研究组 & 干预措施
Optional Continued Access
Experimental
Part 2
干预措施: DSP-5336 (Drug)
DSP-5336 tablets and [14C]-DSP-5336 solution
Experimental
Part 1
干预措施: [14C]-DSP-5336 (Drug)
DSP-5336 tablets and [14C]-DSP-5336 solution
Experimental
Part 1
干预措施: DSP-5336 (Drug)
结局指标
主要结局
Total recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336
时间窗: Day 1 to 4, max 7 days if less than 90% is collected by Day 4
The percentage of dose excreted in urine
Total recovery of radioactivity in fecal waste as percentage of total radioactive dose of [14C]-DSP-5336
时间窗: Day 1 to 4, max 7 days if less than 90% is collected by Day 4
The percentage of dose excreted in fecal waste
Total recovery of radioactivity in excreta balance as percentage of total radioactive dose of [14C]-DSP-5336
时间窗: Day 1 to 4, max 7 days if less than 90% is collected by Day 4
The percentage of dose excreted in combined urine and fecal waste
Relative abundance (mean value) of [14C]-DSP-5336
时间窗: 4 days, max 7 days
Plasma samples will be analyzed for \[14C\]-DSP-5336 and its metabolites.
次要结局
- Area under the plasma concentration time profile from time zero to time of the last quantifiable concentration (AUClast) of [14C]-DSP-5336(4 days, max 7 days)
- Cmax for the relative bioavailability of [14C]-DSP-5336(4 days, max 7 days)
- t(1/2) of [14C]-DSP-5336(4 days, max 7 days)
- Ratio of plasma to whole blood total radioactivity(4 days, max 7 days)
- Number of participants with adverse events and serious adverse events(30 days)
研究者
研究点 (2)
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