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A Two-Part, Single-Dose Study of the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (MK-8931-009 [P08535])

2015年1月23日 更新者:Merck Sharp & Dohme LLC

An Open-Label, Two-Part, Single-Dose Study to Investigate the Pharmacokinetics of MK-8931 in Subjects With Renal Insufficiency (Protocol No. MK-8931-009 [P08535])

This study will assess the pharmacokinetics of MK-8931, a ß-secretase inhibitor, in participants with renal insufficiency. In Part 1 of the study, pharmacokinetics of MK-8931 in participants with severe renal disease and in healthy matched control participants will be studied. If data from Part 1 confirms that severe renal impairment does not alter the pharmacokinetics of MK-8931 to the extent requiring dosage adjustment, then no further study will be required and Part 2 will be optional. If the data does not support this conclusion, then Part 2 will be conducted to study the pharmacokinetics of MK-8931 in participants with moderate and mild renal impairment compared to healthy matched controls.

研究概览

地位

完全的

干预/治疗

研究类型

介入性

注册 (实际的)

12

阶段

  • 阶段1

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 85年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Body Mass Index ≤39 kg/m^2
  • No clinically significant abnormality on electrocardiogram
  • Female participant must be postmenopausal or surgically sterilized
  • Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse, during the trial and for 3 months after stopping the medication

Inclusion Criteria Specific to Renally Impaired Participants:

  • Clinical diagnosis of renal insufficiency based on Estimated Glomerular Filtration rate (eGFR): severely decreased eGFR, defined as <30 mL/min/1.73m^2 and participant is not on dialysis; moderately decreased eGFR, defined as ≥30 to <60 mL/min/1.73m^2; mildly decreased eGFR, defined as ≥60 to <80 mL/min/1.73m^2
  • Stable baseline health based on medical history, physical examination, vital signs, and laboratory tests

Inclusion Criterion Specific to Healthy Participants:

  • eGFR ≥80 mL/min/1.73m^2

Exclusion Criteria:

  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug, including history or presence of inflammatory bowel disease, gastrointestinal or rectal bleeding; presence of active ulcer; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; history of pancreatic injury or pancreatitis; history or presence of liver disease or liver injury; history of urinary obstruction or difficulty in voiding
  • History of any infectious disease within 4 weeks prior to drug administration
  • Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or human immunodeficiency virus (HIV)
  • History of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of Long QT Syndrome)
  • Participant has had a kidney removed or has a functioning renal transplant
  • History of alcohol or drug abuse in the past 2 years
  • Blood donation or loss of significant volume of blood in the past 60 days prior to dosing
  • Previously received MK-8931
  • History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • History of malignancy occurring within the 5 years immediately before screening, except for a participant who has been adequately treated for basal cell or squamous cell skin cancer; or in situ cervical cancer; or

localized prostate carcinoma; or has undergone potentially curative therapy with no evidence of recurrence ≥1 year post-therapy

Exclusion Criteria Specific to Renally Impaired Participants:

  • Rapidly fluctuating renal function as determined by historical measurements
  • Suspected renal artery stenosis

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Part 1, Panel A - Severe Renal Impairment Group
Single dose, administered as oral capsules
实验性的:Part 1, Panel B - Healthy Control Group to Match Panel A
Single dose, administered as oral capsules
实验性的:Part 2, Panel C - Moderate Renal Impairment Group
Single dose, administered as oral capsules
实验性的:Part 2, Panel D - Healthy Control Group to Match Panel C
Single dose, administered as oral capsules
实验性的:Part 2, Panel E - Mild Renal Impairment Group
Single dose, administered as oral capsules
实验性的:Part 2, Panel F - Healthy Control Group to Match Panel E
Single dose, administered as oral capsules

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MK-8931
大体时间:Predose through 120 hours post single dose of MK-8931
Predose through 120 hours post single dose of MK-8931

次要结果测量

结果测量
大体时间
Renal clearance (CLr) of MK-8931
大体时间:Predose through 120 hours post single dose of MK-8931
Predose through 120 hours post single dose of MK-8931
Fraction of MK-8931 dose excreted in urine (fe)
大体时间:Predose through 120 hours post single dose of MK-8931
Predose through 120 hours post single dose of MK-8931

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年3月1日

初级完成 (实际的)

2012年5月1日

研究完成 (实际的)

2012年5月1日

研究注册日期

首次提交

2012年2月17日

首先提交符合 QC 标准的

2012年2月17日

首次发布 (估计)

2012年2月23日

研究记录更新

最后更新发布 (估计)

2015年1月26日

上次提交的符合 QC 标准的更新

2015年1月23日

最后验证

2015年1月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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