A Single-Center, Non-Randomized, Open-Label, One-Sequence, Two-Period Within-Subject Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Multiple Doses of Balovaptin In Healthy Volunteers
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
- Maximum Plasma Concentration (Cmax) for M3 Metabolite
研究概览
简要总结
This study was a single-center, non-randomized, open-label, one-sequence, two-period, within-subject study to investigate the effects of multiple doses of rifampicin on the PK and safety of multiple doses of balovaptan in healthy subjects. 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.
- •Rifampicin-related Exclusion Criteria:
- •Subjects diagnosed, or suspected of having porphyria, and subjects with first-degree relatives diagnosed, or suspected of having porphyria.
- •Known hypersensitivity to rifampicin
研究组 & 干预措施
Balovaptan + Rifampicin
Participants received the study drugs in 2 periods. There was a minimum of a 14-day to a maximum of a 21-day washout between the last dose in Period 1 and the first dose in Period 2.
干预措施: Balovaptan (Drug)
Balovaptan + Rifampicin
Participants received the study drugs in 2 periods. There was a minimum of a 14-day to a maximum of a 21-day washout between the last dose in Period 1 and the first dose in Period 2.
干预措施: Rifampicin (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) for M3 Metabolite
时间窗: Day 10 of Period 1 and Day 16 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 Plasma Concentration Curve From Time 0 to 24 Hours for M2 Metabolite
时间窗: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.
Maximum Plasma Concentration (Cmax) for M2 Metabolite
时间窗: Day 10 of Period 1 and Day 16 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 Plasma Concentration Curve From Time 0 to 24 Hours (AUC0-24) for Balovaptan
时间窗: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.
Maximum Plasma Concentration (Cmax) for Balovaptan
时间窗: Day 10 of Period 1 and Day 16 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 Plasma Concentration Curve From Time 0 to 24 Hours for M3 Metabolite
时间窗: Day 10 and 11 of Period 1; Day 16 and 17 of Period 2
AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.
次要结局
- Metabolite to Parent Ratio for M3 Metabolite Based on AUC0-24(Day 10 and 11 of Period 1; Day 16 and 17 of Period 2)
- Percentage of Participants With Adverse Events(Up to 21 days postdose)
- Time to Maximum Observed Plasma Concentration for M2 Metabolite(Day 10 of Period 1 and Day 16 of Period 2)
- Metabolite to Parent Ratio for M2 Metabolite Based on AUC0-24(Day 10 and 11 of Period 1; Day 16 and 17 of Period 2)
- Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan(Day 10 of Period 1 and Day 16 of Period 2)
- Metabolite to Parent Ratio for M2 Metabolite Based on Cmax(Day 10 of Period 1 and Day 16 of Period 2)
- Time to Maximum Observed Plasma Concentration for M3 Metabolite(Day 10 of Period 1 and Day 16 of Period 2)
- Metabolite to Parent Ratio for M3 Metabolite Based on Cmax(Day 10 of Period 1 and Day 16 of Period 2)