A Single-Center, Non-Randomized, Open-Label, One-Sequence, Two-Period Within-Subject Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Multiple Doses of Balovaptan in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) for M3 Metabolite
研究概览
简要总结
This study was a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. The study was conducted at 1 site in the Netherlands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
- •Body Mass Index of 18 to 30 kg/m2, inclusive.
- •For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
- •For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.
排除标准
- •Female subjects who are pregnant or lactating.
- •Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.
研究组 & 干预措施
Balovaptan + Itraconzole
Dosing in Period 1 was separated by at least a 7 day washout period before dosing starts in Period 2. Participants received the study drugs in 2 periods over a total of 37 days.
干预措施: Balovaptan (Drug)
Balovaptan + Itraconzole
Dosing in Period 1 was separated by at least a 7 day washout period before dosing starts in Period 2. Participants received the study drugs in 2 periods over a total of 37 days.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) for M3 Metabolite
时间窗: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for Balovaptan
时间窗: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M3 Metabolite
时间窗: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for M3 Metabolite
时间窗: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Maximum Plasma Concentration (Cmax) for Balovaptan
时间窗: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
Maximum Plasma Concentration (Cmax) for M2 Metabolite (as Applicable)
时间窗: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M2 Metabolite (as Applicable)
时间窗: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan
时间窗: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for M2 Metabolite (as Applicable)
时间窗: Day 10 of Period 1; Day 10 and Day 15 of Period 2
次要结局
- Trough Plasma Concentration (Ctrough) for M2 Metabolite (as Applicable)(Day 10 of Period 1; Day 10 and Day 15 of Period 2)
- Time to Steady State for Balovaptan(Days 1, 3, 5, 8, 9, 10 in Period 1 and Days 1, 3, 5, 8, 9, 10, 13, 14, 15 in Period 2)
- Percentage of Participants With Adverse Events(Up to 21 days postdose)
- Trough Plasma Concentration (Ctrough) for Balovaptan(Day 10 of Period 1; Day 10 and Day 15 of Period 2)
- Trough Plasma Concentration (Ctrough) for M3 Metabolite(Day 10 of Period 1; Day 10 and Day 15 of Period 2)