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 Olinciguat (IW-1701)
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
- Maximum Observed Plasma Concentration (Cmax) of olinciguat
研究概览
简要总结
To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics (PK) of olinciguat
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is an ambulatory adult and between 18 and 55 years old (inclusive) 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 kg/m2 at the screening visit
- •Women of reproductive potential must have a negative pregnancy test at screening at at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and until 90 days after receiving the final study drug dose
- •Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and until 90 days after receiving the final study drug dose
- •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 (except for hormonal birth control)
- •Other exclusion criteria per protocol
研究组 & 干预措施
Healthy Volunteers
Period 1: Single dose of olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose.
干预措施: Olinciguat (Drug)
Healthy Volunteers
Period 1: Single dose of olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of olinciguat
时间窗: Predose and up to 8 days post first olinciguat dose
Area under the plasma concentration time curve from time zero (predose) extrapolated to infinity (AUCinf)
时间窗: Predose and up to 8 days post first olinciguat dose
次要结局
- Number of subjects with ≥1 treatment-emergent adverse event (TEAE) in Period 1 vs Period 2(51 days post first olinciguat dose)
- Cmax of Itraconazole(First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days))
- Area under the concentration-time curve during a dosing interval (AUCtau) for itraconazole and hydroxy-itraconazole(Period 2 (Period 2 duration can be up to 13 days) predose and up to 24 hour after 2nd olinciguat dose)
- Cmax of hydroxy-Itraconazole(First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days))