A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Maximum Observed Serum Concentration (Cmax)
研究概览
简要总结
This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 19 to 40 kg/m^2, inclusive
- •Moderate renal impairment and severe renal impairment and/or end-stage renal disease (ESRD) who may require hemodialysis and normal renal function
- •Free of any clinically significant disease (except those related to renal disease and comorbid conditions) that requires a physician's care and would interfere with the study
- •Females of reproductive potential must have used a medically accepted method of contraception for three months prior to screening and must agree to use an accepted contraceptive method during and for two months following the study
- •Males must agree to use a medically accepted method of contraception during the trial and for 3 months after the study
排除标准
- •Pregnant, intend to become pregnant, or breastfeeding
- •Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
- •History of any infectious disease within 4 weeks prior to study drug administration that affects ability to participate in the study
- •Positive for hepatitis B surface antigen, and/or for human immunodeficiency virus (HIV) antibodies. Healthy participants positive for hepatitis C antibodies
- •Previously received PegIntron®, Sylatron®, and/or Pegasys
- •More than 10 cigarettes or equivalent tobacco use per day
- •History of malignancy
- •Hypothyroidism or hyperthyroidism
- •History of depression requiring treatment with psychotherapy or medication
- •History of suicidality or at risk of self-harm or harm to others
- •History of autoimmune disorder requiring medical therapy
- •Immune mediated renal insufficiency
- •Removal of a kidney (healthy participants) or functioning renal transplant (participants with renal impairment)
研究组 & 干预措施
Healthy Participants
Participants with normal renal function defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
干预措施: PegIFN-2b (Sylatron®) (Drug)
Participants with Moderate Renal Impairment
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
干预措施: PegIFN-2b (Sylatron®) (Drug)
Participants with Severe Renal Impairment
Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
干预措施: PegIFN-2b (Sylatron®) (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax)
时间窗: From hour 0 (pre-dose) to 288 hours post-dose
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Apparent Terminal Half-life (T1/2)
时间窗: From hour 0 (pre-dose) up to 288 hours post-dose
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
时间窗: From hour 0 (pre-dose) to 288 hours post-dose
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
Time to Maximum Observed Serum Concentration (Tmax)
时间窗: From hour 0 (pre-dose) up to 288 hours post-dose
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
Apparent Total Body Clearance (CL/F)
时间窗: From hour 0 (pre-dose) up to 288 hours post-dose
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
AUC From Time 0 to the Last Measurable Sample (AUC0-last)
时间窗: From hour 0 (pre-dose) up to 288 hours post-dose
AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.
Apparent Volume of Distribution (Vd/F)
时间窗: From hour 0 (pre-dose) up to 288 hours post-dose
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
次要结局
未报告次要终点