A Phase 1, Single-arm, Open-label Study to Evaluate the Pharmacokinetics and Safety of Intravenous Difelikefalin in Adult Chinese Subjects on Haemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1
研究概览
简要总结
This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects. Treatment period is one week and there is a safety follow-up period of 1 week.
详细描述
This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects.
Total study duration for a single subject is up to 5 weeks including a screening period of up to 3 weeks, a treatment period of 1 week, and a safety follow-up period of 1 week.
The duration of PK sampling is 12 days.
The primary objective of the study is to evaluate the PK profile of a repeated (3 times weekly) dose of difelikefalin in Chinese HD subjects over a 1-week treatment period.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage renal disease (ESRD) subjects who have been on HD for at least 3 months before enrolment in the study and are currently on HD 3 times per week.
- •Subjects with a prescription dry body weight between 40 and 100 kg, inclusive.
- •If female, is not pregnant, or nursing
- •If female:
- •Is surgically sterile; or
- •Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or
- •Has a negative serum pregnancy test within 7 days before first dose of investigational product, and agrees to use adequate contraceptive precautions (e.g., hormonal contraceptives, barrier with spermicide, intrauterine device, vasectomised partner, or abstinence) from the time of informed consent until 7 days after the last dose of investigational product.
- •If male, agrees not to donate sperm from the first dose of investigational product administration (Day 1) until 7 days after last dosing, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after the last dose of investigational product.
排除标准
- •Planned or anticipated to receive a kidney transplant during the study.
- •Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 × the reference upper limit of normal (ULN), or bilirubin (total) greater than 4 × the ULN at screening.
- •Subjects with severe hepatic impairment (Child-Pugh Class C).
- •Known history of allergic reaction to opiates such as hives. Note: Side effects related to the use of opioids such as constipation or nausea would not exclude the subjects from the study.
- •Subject has known hypersensitivity to the study intervention or any component of the investigational product formulation.
研究组 & 干预措施
1-week, single arm, open label treatment phase
干预措施: Difelikefalin Injection (Drug)
结局指标
主要结局
Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 1
时间窗: 1 week
Cmax = Maximum (peak) observed plasma concentration
Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 1
时间窗: 1 week
Tmax = Time to reach maximum observed plasma concentration
Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 1
时间窗: 1 week
AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"
AUCinf - Dose 1
时间窗: 1 week
AUCinf = AUC from time zero to infinity
AUCextrap(%) - Dose 1
时间窗: 1 week
AUCextrap(%) = percentage of AUCinf based on extrapolation
t½ - Dose 1
时间窗: 1 week
t½ = elimination half-life
Clearance - Dose 1
时间窗: 1 week
Clearance = the volume of blood or plasma that can be freed of a specified constituent in a specified time by its excretion into the urine through the kidneys
Evaluation of the PK Profile of Difelikefalin - Tmax - Dose 3
时间窗: 1 week
Tmax = Time to reach maximum observed plasma concentration
Vz - Dose 1
时间窗: 1 week
Vz = volume of distribution
Evaluation of the PK Profile of Difelikefalin - Cmax - Dose 3
时间窗: 1 week
Cmax = Maximum (peak) observed plasma concentration
Evaluation of the PK Profile of Difelikefalin - AUC0-t - Dose 3
时间窗: 1 week
AUC0-t = Area under the concentration-versus-time curve (AUC) from time zero to time "t"
AUCinf - Dose 3
时间窗: 1 week
AUCinf = AUC from time zero to infinity
AUCextrap(%) - Dose 3
时间窗: 1 week
AUCextrap(%) = percentage of AUCinf based on extrapolation
t½ - Dose 3
时间窗: 1 week
t½ = elimination half-life
次要结局
未报告次要终点