A Phase 1, Open-label, Randomized, 2-Treatment, 2-Period, Crossover Study to Assess the Bioequivalence of Navlimetostat Wet-Granulation Tablet Versus the Dry-Granulation Tablet Formulation in Healthy Adult Female (as Assigned at Birth) Participants Who Are Individuals Not of Childbearing Potential
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Number of participants with clinically significant changes in vital signs (VS)
概览
简要总结
This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 be healthy adult INOCBP female with no clinically significant findings on medical history, PE, VS, 12-lead ECGs, or clinical laboratory determinations, as assessed by the investigator.
- •Participants must have BMI of 18.0 to 35.0 kg/m
- •Participants must have adequate laboratory test results for renal and hepatic function, as assessed by the investigator, defined as eGFR ≥ 90 mL/min/1.73m2 using the CKD-EPI equation (screening only), and total bilirubin, ALP, GGT, AST, ALT ≤ 1.5 × ULN.
排除标准
- •Participant must not have any significant acute or chronic medical illness (in the assessment of the investigator).
- •Participant must not have current or recent GI disease: Any gastrointestinal disease within 3 months of study intervention administration that could possibly affect drug absorption, distribution, metabolism, and excretion (eg, bariatric procedure, history of pancreatitis, uncontrolled nausea or vomiting) in the opinion of the investigator.
- •Other protocol defined inclusion/exclusion criteria applies.
研究组 & 干预措施
Treatment A
干预措施: Navlimetostat (Drug)
Treatment B
干预措施: Navlimetostat (Drug)
结局指标
主要结局
Number of participants with clinically significant changes in vital signs (VS)
时间窗: Up to Day 17
Maximum Plasma Concentration (Cmax)
时间窗: Up to Day 17
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
时间窗: Up to Day 17
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
时间窗: Up to Day 17
Number of participants with Adverse Events (AE)
时间窗: Up to approximately day 37
Number of participants with Serious Adverse Events (AE)
时间窗: Up to approximately day 37
Number of participants with clinically significant changes in Physical Examinations (PE)
时间窗: Up to Day 17
Number of participants with clinically significant changes in 12-lead ECGs
时间窗: Up to Day 17
Number of participants with clinically significant changes in laboratory tests results
时间窗: Up to Day 17
次要结局
- Time of maximum observed drug concentration (Tmax)(Up to Day 17)
- Terminal elimination half-life (T-HALF)(Up to Day 17)
- Apparent total body clearance (CLT/F)(Up to Day 17)
- Apparent volume of distribution during the terminal phase (Vz/F)(Up to Day 17)
- Mean residence time (MRT)(Up to Day 17)