NCT07837115尚未招募1 期
A Phase 1, Open-label, Randomized, Single-dose Study to Assess the Relative Bioavailability of Irafamdastat (BMS-986368) Oral Disintegrating Tablet, Oral Disintegrating Tablet Suspension, and Capsule Sprinkles to the Reference Capsule and to Assess the Food Effect on the Pharmacokinetics of Irafamdastat Administered as Oral Disintegrating Tablet in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Celgene
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
研究概览
简要总结
The purpose of this study is to evaluate the relative bioavailability of irafamdastat and to assess food-effect on the pharmacokinetics (PK) of irafamdastat ODT in healthy adult participants.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non-pregnant and non-nursing female (as assigned at birth).
- •BMI between 18.0 and 33.0 kg/m2, inclusive.
排除标准
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population at screening and Day 1 predose, confirmed by repeat.
- •Other protocol-defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
Treatment D
Experimental
干预措施: Irafamdastat (Drug)
Treatment E
Experimental
干预措施: Irafamdastat (Drug)
Treatment A
Experimental
干预措施: Irafamdastat (Drug)
Treatment B
Experimental
干预措施: Irafamdastat (Drug)
Treatment C
Experimental
干预措施: Irafamdastat (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
时间窗: Up to Day 19
Maximum observed plasma concentration (Cmax)
时间窗: Up to Day 19
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to Day 19
次要结局
- Volume of distribution of terminal phase (Vz/F)(Up to Day 19)
- Time of maximum observed plasma concentration (Tmax)(Up to Day 19)
- Terminal elimination half-life (T-HALF)(Up to Day 19)
- Apparent total body clearance (CLT/F)(Up to Day 19)
- Number of participants with adverse events (AEs)(Up to Day 28 days after last dose)
- Number of participants with serious AEs (SAEs)(Up to Day 28 days after last dose)
- Number of participants with vital sign abnormalities(Up to Day 21)
- Number of participants with physical examination abnormalities(Up to Day 21)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 21)
- Number of participants with clinical laboratory abnormalities(Up to Day 18)
- Number of participants with treatment-emergent suicidal ideation and behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to Day 21)
- Change in anziety as assessed by Beck Anxiety Inventory (BAI)(Up to Day 21)
研究者
研究点 (1)
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