A Single-center, Open Label, Single-dose Study to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics of ACT-132577
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) of ACT-132577
研究概览
简要总结
The primary purpose of this study is to investigate the fate of ACT-132577 in healthy subjects and in people with severe kidney disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •ALL SUBJECTS:
- •Signed informed consent in the local language prior to any study-mandated procedure;
- •Male/female aged 18 to 65 years (inclusive) at screening;
- •Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening. Body weight at least 50 kg;
- •Women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls up to 30 days after the end of study treatment.
- •HEALTHY SUBJECTS:
- •Normal renal function confirmed by the estimated glomerular filtration rate (eGFR) determined at screening;
- •Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
- •SEVERE RENAL FUNCTION IMPAIRMENT SUBJECTS:
- •Severe renal function impairment is defined by eGFR estimated at screening between 15 mL/min/1.73 m2 and 29 mL/min/1.73 m2 (inclusive).
排除标准
- •ALL SUBJECTS:
- •Pregnant or lactating women;
- •Known hypersensitivity to ACT-132577 or drugs of the same class, or any of their excipients;
- •Known hypersensitivity or allergy to natural rubber latex;
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- •SEVERE RENAL FUNCTION IMPAIRMENT SUBJECTS:
- •End-stage renal disease that requires dialysis;
- •Hemoglobin concentration < 9 g/dL;
- •History of severe renal stenosis;
- •Serum potassium concentration > 5.5 mmol/L;
- •Presence of severe cardiac disease;
- •History of clinically relevant bleeding disorder;
- •Presence of any organ disorder, with the exception of renal function impairment, or use of any medication which might interfere with the pharmacokinetics of ACT-132577;
- •Known life-threatening disease with a life expectancy of less than 1 year;
- •Presence of unstable diabetes mellitus.
研究组 & 干预措施
ACT-132577 (50 mg)
8 healthy subjects and 8 subjects with severe renal function impairment will receive a single oral dose of 50 mg ACT-132577 administered as capsule following an overnight fast
干预措施: ACT-132577 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of ACT-132577
时间窗: From baseline to up to 16 days
Cmax of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of ACT-132577
时间窗: From baseline to up to 16 days
AUC(0-T) of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)]
时间窗: From baseline to up to 16 days
AUC(0-inf) of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
次要结局
- Incidence of adverse events leading to premature discontinuation of study treatment(From baseline to up to 16 days)
- Incidence of any clinical relevant findings in ECG variables(From baseline to up to 16 days)
- Incidence of treatment-emergent adverse events(From baseline to up to 16 days)
- Time to reach Cmax (tmax) of ACT-132577(From baseline to up to 16 days)
- Terminal half-life [t(1/2)](From baseline to up to 16 days)