A Phase 1, Fixed Sequence, Open-label Study in Healthy Adult Subjects to Evaluate the Effect of Multiple Doses of Rabeprazole on the Pharmacokinetics of a Single Dose of Vadadustat
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) for vadadustat
研究概览
简要总结
This is a Phase 1, fixed sequence, open-label study to evaluate the effect of multiple oral doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat 300 mg in healthy male and female subjects.
详细描述
This is a Phase 1, fixed sequence, open-label study in healthy adult subjects to evaluate the effect of multiple doses of rabeprazole on the pharmacokinetics of a single dose of vadadustat in healthy male and female subjects. Approximately twenty (20) subjects, with at least 30% female subjects, will be enrolled to ensure 18 evaluable subjects. Subjects will be on study for up to 66 days, including a 28-day screening period, 9-day clinic period, and a 30-day follow- up period post last dose. Subjects who are confirmed eligible and receive at least one dose of study drug will be considered enrolled in the study. Blood samples for PK analysis will be collected at pre-defined time points throughout the study up to 48 hours post administration of vadadustat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Healthy Male or female between 18 and 55 years of age, inclusive, at time of informed consent
- •Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive.
排除标准
- •Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
- •Positive test results for human immunodeficiency virus (HIV) antibody; Positive test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCVab) within 3 months prior to screening , or positive test results for human immunodeficiency virus antibody (HIVab) at Screening
- •Taking any prescription medication or over the counter multi-vitamin supplement, or any non-prescription products (including herbal-containing preparations but excluding acetaminophen) within 14 days prior to Day -1.
研究组 & 干预措施
Rabeprazole and Vadadustat
Subjects will receive vadadustat 300 mg on day 1, rabeprazole 20 mg every 12 hours on days 2 through 5 and vadadustat 300 mg and rabeprazole on day 6
干预措施: Vadadustat (Drug)
Rabeprazole and Vadadustat
Subjects will receive vadadustat 300 mg on day 1, rabeprazole 20 mg every 12 hours on days 2 through 5 and vadadustat 300 mg and rabeprazole on day 6
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) for vadadustat
时间窗: Up to 10 weeks
Area under plasma concentration-time curve from 0 to infinity (AUCinf) for vadadustat
时间窗: Up to 10 weeks
Maximum observed plasma concentration (Cmax) for vadadustat
时间窗: Up to 10 weeks
次要结局
- Time to maximum observed plasma concentration (Tmax) of vadadustat(Up to 10 weeks)
- Reporting of treatment emergent adverse event (TEAE) as reported by study subjects(Up to 10 weeks)
- Area under plasma concentration-time curve from 0 to infinity (AUCinf) of vadadustat-O-glucuronide(Up to 10 weeks)
- Maximum observed plasma concentration (Cmax) of vadadustat-O-glucuronide(Up to 10 weeks)
- Percent of extrapolated area under the curve from time t to infinity (%AUCextrap) of vadadustat(Baseline and end of study)
- Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast) of vadadustat-O-glucuronide(Up to 10 weeks)
- Elimination rate constant (Kel) of vadadustat(Up to 10 weeks)
- Terminal half-life (t½) of vadadustat(Up to 10 weeks)
- Apparent total body clearance (CL/F) of vadadustat(Up to 10 weeks)