A Phase 1 Study to Evaluate the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of [14C]Navlimetostat (BMS-986504) at Steady State in Healthy Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- TRA from UR
研究概览
简要总结
The purpose of this study is to evaluate the metabolism, the routes and extent of elimination, and drug levels of [14C]Navlimetostat (BMS-986504) in healthy female participants
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must have a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
- •Participants must have a recent history (ie, last month) of a minimum of 1 bowel movement per 2 days.
- •Participants must be female (as assigned at birth) who is an individual not of childbearing potential (INOCBP), defined as one of the following:.
- •i) Surgically sterile (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
- •ii) Postmenopausal, defined as ≥ 12 consecutive months of amenorrhea in an individual over the age of 45 years (no other biological or physiological causes), and individuals < 55 years of age with 12 months of amenorrhea must have serum FSH levels > 40 mIU/mL at screening to confirm menopausal status.
排除标准
- •Participants must not have any significant acute or chronic medical illness.
- •Participants must not have current or recent gastrointestinal disease.
- •Participants must not have a history of prolonged bleeding or excessive bruising.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part A
干预措施: Navlimetostat (Drug)
Part B
干预措施: [14C]Navlimetostat (Drug)
结局指标
主要结局
TRA from UR
时间窗: Up to 14 days
TRA from %UR
时间窗: Up to 14 days
Time of maximum observed plasma concentration (Tmax)
时间窗: Up to 14 days
Percent of administered dose recovered in urine (%UR)
时间窗: Up to 14 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
时间窗: Up to 14 days
Renal clearance (CLR)
时间窗: Up to 14 days
Maximum observed plasma concentration (Cmax)
时间窗: Up to 14 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to 14 days
Terminal elimination half-life (T-HALF)
时间窗: Up to 14 days
Apparent total body clearance (CLT/F)
时间窗: Up to 14 days
Apparent volume of distribution during the terminal phase (VZ/F)
时间窗: Up to 14 days
Percent of plasma navlimetostat AUC(INF) to plasma radioactivity AUC(INF) (%AUC(INF))
时间窗: Up to 14 days
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
时间窗: Up to 14 days
Total amount of dose recovered in urine (UR)
时间窗: Up to 14 days
TRA from total amount of dose recovered in feces (FR)
时间窗: Up to 14 days
TRA from percent of administered dose recovered in feces (%FR)
时间窗: Up to 14 days
TRA from total amount of radioactivity recovered (Rtotal)
时间窗: Up to 14 days
TRA from total percent of radioactivity recovered (%TOTAL)
时间窗: Up to 14 days
TRA amount recovered of the radioactive dose in vomit, if applicable
时间窗: Up to 14 days
TRA fraction of the radioactive dose in vomit, if applicable
时间窗: Up to 14 days
次要结局
- Cmax(Up to 14 days)
- Tmax(Up to 14 days)
- Area under the plasma concentration-time curve over 1 dosing interval (AUC(TAU))(Up to 14 days)
- Trough observed plasma concentration (Ctrough)(Up to 14 days)
- Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax)(Up to 14 days)
- Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU))(Up to 14 days)
- Number of participants with treatment-emergent adverse events (TEAEs)(Up to 14 days)
- Number of participants with serious adverse events (SAEs)(Up to 14 days)
- Number of participants with clinically significant changes in physical examinations(Up to 14 days)
- Number of participants with clinically significant changes in vital signs(Up to 14 days)
- Number of participants with clinically significant changes in 12-lead ECGs(Up to 14 days)
- Number of participants with clinically significant changes in clinical laboratory test results(Up to 14 days)