NCT01888393已完成1 期
A Phase 1, Open Label Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F
研究概览
简要总结
This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Group A: Subjects with Moderate Hepatic Impairment
- •Male and female 18 to 65 years of age (inclusive)
- •Satisfy the criteria for moderate hepatic impairment defined as a Child Pugh total score of 7 to 9 (Child Pugh Class B) at the Screening Visit
- •Willing and able to comply with schedule visits, treatment, laboratory tests, and contraceptive guidelines.
- •Group B: Healthy subjects
- •Male and female 18 to 65 years of age (inclusive)
- •Healthy subjects with no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG, and clinical laboratory tests
- •Willing and able to comply with schedule visits, treatment, laboratory tests, contraceptive guidelines and other study procedures
排除标准
- •Group A: Subjects with Moderate Hepatic Impairment
- •History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- •Have fluctuating or rapidly deteriorating hepatic function by history or as indicated by significant variations in or worsening of clinical and/or laboratory signs of hepatic impairment within 6 months before the Screening Visit
- •Other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver
- •Severe hepatic encephalopathy
- •Type 1 diabetes mellitus or evidence of poorly controlled type 2 diabetes
- •Hepatocellular carcinoma, HIV, hepatitis B/C
- •Significant renal dysfunction
- •Solid organ or bone marrow transplantation
- •History of regular alcohol consumption, drug abuse or regular smoking
- •Group B: Healthy subjects
- •History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- •History of regular alcohol consumption, drug abuse or regular smoking
研究组 & 干预措施
Group A
Experimental
Approximately 12 subjects (male and female) with moderate hepatic impairment
干预措施: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h (Drug)
Group B
Experimental
Approximately 12 healthy subjects (male and female)
干预措施: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h (Drug)
结局指标
主要结局
Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F
时间窗: 16 days
Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F
时间窗: 16 days
次要结局
- Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC(16 days)
- Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC(16 days)
- Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry(21 days)
研究者
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