NCT01537757已完成1 期
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])
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
- 12
- 主要终点
- Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MK-8931
研究概览
简要总结
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Part 1, Panel A - Severe Renal Impairment Group
Experimental
干预措施: MK-8931 (Drug)
Part 1, Panel B - Healthy Control Group to Match Panel A
Experimental
干预措施: MK-8931 (Drug)
Part 2, Panel C - Moderate Renal Impairment Group
Experimental
干预措施: MK-8931 (Drug)
Part 2, Panel D - Healthy Control Group to Match Panel C
Experimental
干预措施: MK-8931 (Drug)
Part 2, Panel E - Mild Renal Impairment Group
Experimental
干预措施: MK-8931 (Drug)
Part 2, Panel F - Healthy Control Group to Match Panel E
Experimental
干预措施: MK-8931 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MK-8931
时间窗: Predose through 120 hours post single dose of MK-8931
次要结局
- Renal clearance (CLr) of MK-8931(Predose through 120 hours post single dose of MK-8931)
- Fraction of MK-8931 dose excreted in urine (fe)(Predose through 120 hours post single dose of MK-8931)
研究者
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