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临床试验/NCT00812396
NCT00812396已完成1 期

A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism

Merck Sharp & Dohme LLC0 个研究点目标入组 30 人开始时间: 2007年11月1日最近更新:
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
30
主要终点
comparative proteomics on proteins present in the vastus lateralis or plasma

研究概览

简要总结

This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •subject is a healthy male between 18 and 40 years old
  • •subject's weight is stable over the past 3 months
  • •subject agrees to refrain from consuming alcohol during study
  • •subject agrees to consume no caffeine while in the CRU
  • •subject agrees to follow meat-free diet
  • •subject is willing to avoid strenuous activity
  • •subject has been a nonsmoker for at least 6 months

排除标准

  • •subject is a regular user of illicit drugs
  • •subject has taken androgenic steroids in the past 12 months
  • •subject has participated in sports events, resistance training, or moderate to heavy endurance training in the past month
  • •subject has prostate cancer
  • •subject has HIV and/or hepatitis B or C

研究组 & 干预措施

1

Active Comparator

Low dose testosterone

干预措施: Comparator: low dose testosterone (Drug)

2

Active Comparator

High dose testosterone

干预措施: Comparator: high dose testosterone (Drug)

3

Placebo Comparator

Placebo

干预措施: Comparator: placebo (Drug)

结局指标

主要结局

comparative proteomics on proteins present in the vastus lateralis or plasma

时间窗: 1 week

次要结局

  • mRNA or miRNA expression in the vastus lateralis or in peripheral blood(1 week)

研究者

申办方类型
Industry
责任方
Sponsor

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