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Completed

NCT Number: NCT00812396

Biomarkers of Muscle Anabolism (MK-0000-082)

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

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Key information

Conditions

Muscle Anabolism

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Comparator: low dose testosterone

Drug

Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 200 mg (0.8 mL) testosterone.

Comparator: high dose testosterone

Drug

Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 600 mg (2.4 mL) testosterone.

Comparator: placebo

Drug

Subjects will receive two muscle biopsies, the first at baseline, and the second a week after a single intramuscular dose of 0.8 mL placebo saline solution.

Primary outcomes

  1. comparative proteomics on proteins present in the vastus lateralis or plasma

    Time frame: 1 week

Secondary outcomes

  1. mRNA or miRNA expression in the vastus lateralis or in peripheral blood

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2008
Registry last updated
Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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