An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Amount Excreted in Urine (Aeu)
研究概览
简要总结
The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Body weight greater than or equal to (>=) 40 kilograms (kg)
- •Relapsed or refractory (R/R) acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 (NPM1), nucleoporin 98 (NUP98) or nucleoporin 214 (NUP214) gene alterations, and has exhausted, or is ineligible for available therapeutic options
- •Eastern cooperative oncology group (ECOG) performance status grade of 0 or 1
- •Regular bowel movements (that is [i.e.], average production of at least one stool every 2 days)
- •A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
排除标准
- •Acute promyelocytic leukemia or diagnosis of Down syndrome associated leukemia, according to world health organization (WHO) 2016 criteria
- •Active central nervous system (CNS) disease
- •Recipient of solid organ transplant
- •Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to Grade 1 or less
- •Major surgery (e.g., requiring general anesthesia) within 2 weeks prior to first dose of study treatment or has not recovered from surgery or has major surgery planned during the time the participant is receiving study treatment
研究组 & 干预措施
Bleximenib
Participants will receive a single oral dose of 14C-bleximenib on Cycle 1 Day 1. The recommended Phase 2 dose (RP2D) of bleximenib will start on Cycle 1 Day 2 with non-radiolabeled bleximenib and will continue until the end of Cycle 1 (cycle duration=28 days), with subsequent roll-over for eligible participants to 75276617ALE1001 (NCT04811560) for continued non-radiolabeled bleximenib administration as appropriate.
干预措施: 14C-bleximenib (Drug)
Bleximenib
Participants will receive a single oral dose of 14C-bleximenib on Cycle 1 Day 1. The recommended Phase 2 dose (RP2D) of bleximenib will start on Cycle 1 Day 2 with non-radiolabeled bleximenib and will continue until the end of Cycle 1 (cycle duration=28 days), with subsequent roll-over for eligible participants to 75276617ALE1001 (NCT04811560) for continued non-radiolabeled bleximenib administration as appropriate.
干预措施: bleximenib (Drug)
结局指标
主要结局
Amount Excreted in Urine (Aeu)
时间窗: Up to Day 28
Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported.
Amount Excreted in Feces (Aef)
时间窗: Up to Day 28
Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported.
Percentage of Dose Excreted in Urine (feu)
时间窗: Up to Day 28
Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.
Percentage of Dose Excreted in Feces (fef)
时间窗: Up to Day 28
Total amount excreted into the feces expressed as a percentage of the administered dose will be reported.
Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
时间窗: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)
AUC0-t in whole blood and plasma will be reported.
Maximum Observed Concentration (Cmax)
时间窗: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)
Maximum observed concentration in whole blood and plasma will be determined.
次要结局
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 58 days)