A Phase 1, Open-label, Single-dose, Randomized Crossover Study to Evaluate the Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Apparent Total Plasma Clearance (CL/F) of Sitravatinib
研究概览
简要总结
The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations following oral administration in healthy adults.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
- •Able to swallow multiple capsules.
排除标准
- •History of stomach or intestinal surgery or resection
- •Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.
- •Participants who, in the opinion of the Investigator (or designee), should not participate in this study.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Dosing Sequence 1: Sitravatinib Free Base then Malate Salt
Sitravatinib free base capsule 120 mg on Day 1 in Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days
干预措施: Sitravatinib (Drug)
Dosing Sequence 2: Sitravatinib Malate Salt then Free Base
Sitravatinib malate salt capsule 100 mg on Day 1 in Period 1 then sitravatinib free base capsule 120 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days
干预措施: Sitravatinib (Drug)
结局指标
主要结局
Apparent Total Plasma Clearance (CL/F) of Sitravatinib
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Maximum Observed Plasma Concentration (Cmax) of Sitravatinib
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Apparent Volume of Distribution (Vz/F) of Sitravatinib
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
次要结局
- Number of Participants With Adverse Events(Up to Week 8)