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临床试验/NCT00990821
NCT00990821已完成1 期

A Randomized, 5-Part, Intravenous Study of the Safety, Tolerability, Bioequivalence, and Drug Interaction Potential of Final Market Image Formulation of MK0517 in Young Healthy Subjects

Merck Sharp & Dohme LLC0 个研究点目标入组 188 人开始时间: 2005年1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
188
主要终点
Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V
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 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults. Parts I to IV of this study will examine different doses of MK-0517 as well as two different formulations of MK-0517 (with and without polysorbate 80). Part V of the study will compare single doses of intravenous non-PS80 MK-0517 to oral 125-mg capsule of aprepitant. The primary hypothesis for Part V of the study is that a single intravenous dose of 100-mg or 115-mg MK-0517 is area under the plasma-time curve (AUC) equivalent to that of the 125-mg oral aprepitant capsule in young healthy participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Subject is neither grossly overweight nor underweight for his/her height and body build
  • •Subject is in good health -Subject is a nonsmoker
  • •Subject is willing to avoid excessive alcohol consumption for the duration of the study
  • •Subject is willing to avoid strenuous physical activity (i.e. unaccustomed weight lifting, running, bicycling) for the duration of the study
  • •Subject agrees to refrain from consumption of grapefruit (and grapefruit products) before and during the study

排除标准

  • •Subject has a history of multiple and/or severe allergies to drugs or food
  • •Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
  • •Subject has an infection, including Human immunodeficiency virus (HIV) infection
  • •Subject is a regular user of any illicit drug
  • •Subject consumes excessive amounts of alcohol
  • •Subject drinks excessive amounts of coffee, tea, cola or other caffeinated beverages
  • •Subject currently uses on a regular basis, any prescription or non prescription medications

研究组 & 干预措施

Part I, Panel C

Experimental

40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant

干预措施: 40 mg Aprepitant (Drug)

Part V, Treatment Sequence 2

Experimental

100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant

干预措施: 100 mg MK-0517 (PS80) (Drug)

Part I, Panel A

Experimental

100 mg MK-0517 (nonpolysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant

干预措施: 100 MK-0517 (PS80) + 2 mg midazolam (Drug)

Part I, Panel A

Experimental

100 mg MK-0517 (nonpolysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant

干预措施: 100 mg MK-0517 (non-PS80) (Drug)

Part I, Panel A

Experimental

100 mg MK-0517 (nonpolysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant

干预措施: 150 mg MK-0517 (Non-PS80) (Drug)

Part I, Panel A

Experimental

100 mg MK-0517 (nonpolysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant

干预措施: Placebo (Drug)

Part I, Panel A

Experimental

100 mg MK-0517 (nonpolysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant

干预措施: 125 mg Aprepitant (Drug)

Part I, Panel B

Experimental

100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant

干预措施: 100 mg MK-0517 (PS80) (Drug)

Part I, Panel B

Experimental

100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant

干预措施: 150 mg MK-0517 (PS80) (Drug)

Part I, Panel B

Experimental

100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant

干预措施: Placebo (Drug)

Part I, Panel B

Experimental

100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant

干预措施: 125 mg Aprepitant (Drug)

Part I, Panel C

Experimental

40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant

干预措施: 40 mg MK-0517 (non-PS80) (Drug)

Part I, Panel C

Experimental

40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant

干预措施: Placebo (Drug)

Part II

Experimental

2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam

干预措施: 100 mg MK-0517 (PS80) (Drug)

Part II

Experimental

2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam

干预措施: 2 mg Midazolam (Drug)

Part III, Panel 1, Treatment Sequence 1

Experimental

125 mg aprepitant → 90 mg MK-0517 (PS80)

干预措施: 90 mg MK-0517 (PS80) (Drug)

Part III, Panel 1, Treatment Sequence 1

Experimental

125 mg aprepitant → 90 mg MK-0517 (PS80)

干预措施: 40 mg MK-0517 (non-PS80) (Drug)

Part III, Panel 1, Treatment Sequence 1

Experimental

125 mg aprepitant → 90 mg MK-0517 (PS80)

干预措施: 125 mg Aprepitant (Drug)

Part III, Panel 1, Treatment Sequence 2

Experimental

40 mg MK-0517 (non-PS80) → 125 mg aprepitant

干预措施: 40 mg MK-0517 (non-PS80) (Drug)

Part III, Panel 1, Treatment Sequence 2

Experimental

40 mg MK-0517 (non-PS80) → 125 mg aprepitant

干预措施: 125 mg Aprepitant (Drug)

Part III, Panel 2

Experimental

40 mg MK-0517 (non-PS80)

干预措施: 40 mg MK-0517 (non-PS80) (Drug)

Part IV

Experimental

40 mg MK-0517 (non-PS80 formulation)

干预措施: 40 mg MK-0517 (non-PS80) (Drug)

Part V, Treatment Sequence 1

Experimental

125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)

干预措施: 100 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 1

Experimental

125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)

干预措施: 115 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 1

Experimental

125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)

干预措施: 125 mg Aprepitant (Drug)

Part V, Treatment Sequence 2

Experimental

100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant

干预措施: 115 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 2

Experimental

100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant

干预措施: 125 mg Aprepitant (Drug)

Part V, Treatment Sequence 3

Experimental

115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)

干预措施: 100 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 3

Experimental

115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)

干预措施: 115 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 3

Experimental

115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)

干预措施: 125 mg Aprepitant (Drug)

Part V, Treatment Sequence 4

Experimental

125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)

干预措施: 100 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 4

Experimental

125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)

干预措施: 115 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 4

Experimental

125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)

干预措施: 125 mg Aprepitant (Drug)

Part V, Treatment Sequence 5

Experimental

100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)

干预措施: 100 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 5

Experimental

100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)

干预措施: 115 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 5

Experimental

100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)

干预措施: 125 mg Aprepitant (Drug)

Part V, Treatment Sequence 6

Experimental

115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant

干预措施: 100 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 6

Experimental

115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant

干预措施: 115 mg MK-0517 (PS80) (Drug)

Part V, Treatment Sequence 6

Experimental

115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant

干预措施: 125 mg Aprepitant (Drug)

结局指标

主要结局

Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V

时间窗: Up to 72 Hours Post Dose

AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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