An Open-label, 2-Period, Fixed-sequence, Phase 1 Study in Healthy Volunteers to Evaluate the Effect of Itraconazole, a Potent CYP3A Inhibitor, on the Pharmacokinetics of IW-1973
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf])
研究概览
简要总结
The primary objective of the study is to evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics of IW-1973.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is an ambulatory adult between 18 and 75 years old at the screening visit
- •Subject is in good health and has no clinically significant findings on physical examination
- •Body mass index is > 18 and < 30.0 kg/m2 at the screening visit
- •Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 2 months after the final dose of study drug
- •Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 2 months after the final dose of study drug
- •Other inclusion criteria per protocol
排除标准
- •Any active or unstable clinically significant medical condition
- •Use of any prescribed or non-prescribed medication
- •Other exclusion criteria per protocol
研究组 & 干预措施
Healthy Volunteers
Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose.
干预措施: IW-1973 (Drug)
Healthy Volunteers
Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf])
时间窗: Predose and up to 14 days post dose of IW-1973
Maximum Observed Plasma Concentration (Cmax) of IW-1973
时间窗: Predose and up to 14 days post dose of IW-1973
次要结局
- Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973(Predose and up to 14 days post dose of IW-1973)
- Apparent Terminal Rate Constant (lambda[z]) of IW-1973(Predose and up to 14 days post dose of IW-1973)
- Apparent Total Plasma Clearance (CL/F) of IW-1973(Predose and up to 14 days post dose of IW-1973)
- Time to Cmax (Tmax) of IW-1973(Predose and up to 14 days post dose of IW-1973)
- Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973(Predose and up to 14 days post dose of IW-1973)
- Apparent Terminal Half-Life (t1/2) of IW-1973(Predose and up to 14 days post dose of IW-1973)
- Apparent Volume of Distribution (Vz/F) of IW-1973(Predose and up to 14 days post dose of IW-1973)