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临床试验/NCT01197911
NCT01197911已完成1 期

The Effect of Hepatic Impairment on the Pharmacokinetics of Aleglitazar: A Multiple-centre, Open-label Study Following a Single Oral Dose of Aleglitazar to Subjects With Mild or Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function.

Hoffmann-La Roche0 个研究点目标入组 38 人开始时间: 2010年9月最近更新:
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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
38
主要终点
Maximum Plasma Concentration (Cmax) of Aleglitazar
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched control subjects with normal hepatic function. Subjects will receive a single oral dose of aleglitazar, with assessment of the pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled subject is approximately 6 weeks.

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 70 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Male and female adults, 18-70 years of age inclusive
  • •Normal hepatic function or mild to moderate impaired liver function (Child-Pugh class A or B)
  • •Body mass index (BMI) 18 to 40 kg/m2 inclusive
  • •Females must be either surgically sterile, postmenopausal, or willing to use two reliable methods of contraception for the duration of the study and started 3 months before study start

排除标准

  • •For subjects with hepatic impairment: evidence of progressive liver disease within the last 4 weeks, or biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder and/or disease
  • •For healthy volunteers: positive test for hepatitis B or C, alcohol intake of more than 14 units per week, or history of clinically significant alcohol or drug abuse
  • •Acute infection or current malignancy requiring treatment
  • •History of clinically significant allergic disease or drug hypersensitivity
  • •Positive test for HIV-1 or HIV-2 at screening
  • •Participation in a clinical study with an investigational drug or new chemical entity within 2 months prior to screening
  • •Females who are pregnant or lactating

研究组 & 干预措施

Mild impairment

Experimental

干预措施: aleglitazar (Drug)

Moderate impairment

Experimental

干预措施: aleglitazar (Drug)

Normal HF

Experimental

干预措施: aleglitazar (Drug)

结局指标

主要结局

Maximum Plasma Concentration (Cmax) of Aleglitazar

时间窗: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

Cmax was obtained directly from the concentration-time data.

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Aleglitazar

时间窗: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose

AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.

次要结局

  • Cmax of M1 and M6(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Area Under the Plasma Concentration-time Curve From 0 to the Last Quantifiable Time-point Post-dose (AUClast) of Aleglitazar, M1, and M6(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Renal Clearance (CLR) of Aleglitazar, M1, and M6(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72, and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine)
  • Number of Participants With Low and High Vital Signs Values(Days -28 to -2, Day -1, Days 1 to 5, and Day 10 for blood pressure and pulse rate; and Days -28 to -2, Day -1, and Day 10 for oral body temperature)
  • Apparent Total Body Clearance (CL/F) of Aleglitazar(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Apparent Non-renal Clearance (CLNR/F) of Aleglitazar(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine)
  • Elimination Rate Constant (Kel) of Aleglitazar(0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose)
  • Mean of Fraction of Unbound Aleglitazar (fu)(2 and 24 hours post-dose)
  • Time of Maximum Plasma Concentration (Tmax) of Aleglitazar, M1, and M6(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Apparent Volume of Distribution (Vz/F) of Aleglitazar(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine)
  • Amount Excreted in Urine From Time 0 to 48 Hours Post-dose (Ae0-48) of Aleglitazar, M1, and M6(0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose)
  • Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to Infinity (AUCu,Inf)(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Maximum Unbound Plasma Concentration (Cmax,u) of Aleglitazar(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • AUCinf of M1 (RO4408754) and M6 (RO4583746)(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of Aleglitazar, M1, and M6(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Apparent Terminal Half-life (t½) of Aleglitazar, M1, and M6(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Apparent Unbound Volume of Distribution (Vz/Fu) of Aleglitazar(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine)
  • Apparent Unbound Total Body Clearance (CL/Fu) of Aleglitazar(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine)
  • Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), Death, and Study Discontinuation(Up to 6 weeks)
  • Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values(Screening (Days -28 to -2), baseline (Day -1), Days 1 to 5, and follow-up visit (Day 10))
  • Fraction of Drug Excreted in Urine From Time 0 to 48 Hours Post-dose (fe0-48) of Aleglitazar(0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose)
  • Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to 48 Hours Post-dose (AUCu,0-48)(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From 0 to the Last Quantifiable Time-point Post-dose (AUCu,Last)(Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose)
  • Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters(Up to 6 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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