NCT01901133已完成1 期
A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of MDV3100 in Male Subjects With Mild or Moderate Hepatic Impairment and Normal Hepatic Function
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
- 33
- 试验地点
- 1
- 主要终点
- Assessment of pharmacokinetics measured by AUC0-inf following single dose of MDV3100
研究概览
简要总结
This study will assess the influence of hepatic impairment on the pharmacokinetics, safety and tolerability of a single dose of MDV3100 in male subjects.
The study will consist of two treatment arms. Arm A will assess the influence of mild hepatic impairment, and Arm B will assess the influence of moderate hepatic impairment. Data obtained from subjects with hepatic impairment will be compared to data from Body Mass Index (BMI) and age-matched subjects with normal hepatic function.
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 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All subjects must meet all of the following inclusion criteria:
- •Subject must be non-fertile, i.e., surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies
- •Body Mass Index (BMI) of at least 18.5 and no greater than 34.0 kg/m
- •Subjects with mild or moderate hepatic impairment must also meet the following inclusion criteria:
- •Child-Pugh classification Class A (mild, 5 or 6 points) or Class B (moderate, 7 to 9 points) liver function impairment.
排除标准
- •All subjects must not have any of the following characteristics:
- •Known or suspected hypersensitivity to MDV3100 or any components of the formulation used.
- •History of seizure or any condition that may predispose to seizure. Also history of loss of consciousness or transient ischemic attack within 12 months of enrollment (Day 1 visit).
- •Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
- •Abnormal pulse and/or blood pressure (BP) measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic BP >160 mmHg; mean diastolic BP >100 mmHg (BP measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured
- •A QTcF interval of >450 ms after repeated measurements (consistently after duplicate measurements), a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
- •Significant renal dysfunction (creatinine clearance below 60 mL/min, estimated according to the method of modification of diet in renal disease (MDRD) formula).
- •Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
- •Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life.
- •For subjects with normal hepatic function:
- •Regular use of any prescribed or OTC (over-the-counter) drugs, which includes vitamins, natural and herbal remedies (e.g. St John's wort) and food supplements in the 4 weeks prior to admission to the Clinical Unit and use of any drugs in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day).
- •Positive serology test for HBsAg, anti HAV (IgM), anti-HCV, anti-HIV-1 or anti-HIV-
- •For subjects with mild or moderate hepatic impairment:
- •Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period. (e.g. advanced ascites, infection of ascites, fever, active gastrointestinal bleeding).
- •Change in dose regimen of medically required medication within the last two weeks before pre-study examination (allowed co-medication in patients), and/or the use of unallowed co-medication in the 3 weeks prior to admission to the clinical unit (not allowed: any known hepatic enzyme altering agents or compounds known to restrict metabolism).
- •Presence of a hepatocellular carcinoma, or an acute liver disease caused by an infection or drug toxicity.
- •Severe portal hypertension or surgical porto-systemic shunts, including TIPSS (Transjugular intrahepatic portosystemic shunt).
- •Biliary obstruction or other cause of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
- •Signs of significant hepatic encephalopathy (Hepatic encephalopathy score >2).
- •Severe ascites and/or pleural effusion
- •Esophageal variceal bleeding in the medical history.
- •Thrombocyte level below 40x109/L and /or hemoglobin below 90 g/L.
- •Previous liver transplantation.
- •Positive serology test for, anti HAV (IgM), anti-HIV-1 or anti-HIV-2.
研究组 & 干预措施
A: Mild hepatic impairment subjects + control
Experimental
干预措施: MDV3100 (Drug)
B: Moderate hepatic impairment subjects + control
Experimental
干预措施: MDV3100 (Drug)
结局指标
主要结局
Assessment of pharmacokinetics measured by AUC0-inf following single dose of MDV3100
时间窗: Day 1 through Day 50 (25 times)
Area under the plasma concentration - time curve extrapolated to infinity (AUC0-inf) in subjects with mild and moderate hepatic impairment to matched control subjects with normal hepatic function.
Assessment of pharmacokinetics measured by Cmax following single dose of MDV3100
时间窗: Day 1 through Day 50 (25 times)
Maximum concentration (observed) (Cmax) in subjects with mild and moderate hepatic impairment to matched control subjects with normal hepatic function.
次要结局
- Composite of pharmacokinetics following single dose of MDV3100(Day 1 through Day 50 (25 times))
- Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG) and clinical safety laboratory and adverse events(Day 1 through Day 50)
研究者
研究点 (1)
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