A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a 20-mg Dose of Vorasidenib in Subjects With Moderate or Mild Hepatic Impairment and Matched Subjects With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC From Time 0 Extrapolated to Infinity (AUC0-inf) for Vorasidenib
研究概览
简要总结
The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A: Normal Hepatic Function
Participants with normal hepatic function will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1.
干预措施: Vorasidenib (Drug)
Group B: Moderate or Mild Hepatic Impairment
Stage 1: Participants with moderate hepatic impairment (Child-Pugh [C-P] Class B, score of 7 to 9) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1.
Stage 2: Participants with mild hepatic impairment (C-P Class A, score of 5 to 6) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2 will be conducted if a clinically meaningful increase in exposure of vorasidenib is observed in participants with moderate hepatic impairment in Stage 1.
干预措施: Vorasidenib (Drug)
结局指标
主要结局
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) for Vorasidenib
时间窗: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Vorasidenib
时间窗: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Vorasidenib
时间窗: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t) for Vorasidenib
时间窗: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
次要结局
- Apparent Terminal Elimination Half-life (t1/2) of Vorasidenib(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- Apparent Oral Clearance (CL/F) for Vorasidenib(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- Tmax of Metabolite AGI-69460(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- Apparent Volume of Distribution (Vz/F) of Vorasidenib(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- Area Under the Unbound Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t,u) for Vorasidenib(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- AUC0-t for Metabolite AGI-69460(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- Area Under the Unbound Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf,u) for Vorasidenib(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- Maximum Observed Unbound Plasma Concentration (Cmax,u) of Vorasidenib(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- Cmax of Metabolite AGI-69460(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- AUC0-inf for Metabolite AGI-69460(Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose)
- Number of Participants With Adverse Events (AEs)(Up to end of study [EOS] (up to approximately 29 days))
- Number of Participants With Abnormalities in Physical Examination Findings(Up to EOS (up to approximately 29 days))
- Number of Participants With Abnormalities in Vital Signs(Up to EOS (up to approximately 29 days))
- Number of Participants With Abnormalities in 12-Lead Electrocardiogram (ECG) Results(Up to EOS (up to approximately 29 days))
- Number of Participants With Abnormalities in Laboratory Parameters(Up to EOS (up to approximately 29 days))