An Open-Label, Parallel-Group, Phase I Study to Compare the Pharmacokinetics of NKTR-118 Following a Single Oral Dose in Subjects With Renal Impairment and Subjects With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC)
研究概览
简要总结
This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed written and dated informed consent prior to any study specific procedures.
- •Male or female volunteers aged 18 to 80 years (inclusive) having normal renal function, or suffering from moderate or severe renal impairment or ESRD.
- •Male subjects who are sexually active must be willing to use a barrier method of contraception (condom). Women must be of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test (at screening and at each admission) and be using a highly effective form of birth control for 3 months before enrollment and be willing to use a highly effective form of birth control during the study and until 3 months after their last dose of IP.
- •Have a BMI between 18 and 40 kg/m2 (inclusive) and weigh at least 50 kg.
- •Subjects must be able to understand and to comply with study procedures, restrictions and requirements.
排除标准
- •History of any clinically significant medical history which, in the opinion of the Investigator and Sponsor, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.
- •History or presence of gastrointestinal hepatic or other condition known to interfere with disposition of the study drug (except for renal function impairment).
- •Subjects who have a functioning kidney transplant.
- •Acute illness, surgical procedures or trauma from within 2 weeks before enrollment until first administration of study drug
- •Known or suspected history of drug abuse as judged by the Investigator.
研究组 & 干预措施
NKTR118 Group1
Normal Renal Function
干预措施: NKTR118 Group1 (Drug)
NKTR118 Group 2
Moderate Renal Function
干预措施: NKTR118 Group 2 (Drug)
NKTR118 Group 3
Severe Renal Impairment
干预措施: NKTR118 Group3 (Drug)
NKTR118 Group 4
End-Stage Renal Disease
干预措施: NKTR118 (Drug)
结局指标
主要结局
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC)
时间窗: PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose.
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of maximum concentration (Cmax)
时间窗: PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose.
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)
次要结局
- To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing Adverse events.(Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment)
- To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing vital signs(Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment)
- To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing safety blood samples(Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment)