Biomarkers of Muscle Anabolism (MK-0000-082)
A Randomized, Single-Blind, Placebo-Controlled, Fixed-Sequence, Single-Dose, Parallel Design Study to Utilize Comparative Proteomics to Identify Early Biomarkers of Muscle Anabolism
2 other identifiers
interventional
30
0 countries
N/A
Brief Summary
This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2007
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedJanuary 30, 2015
January 1, 2015
3 months
December 19, 2008
January 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
comparative proteomics on proteins present in the vastus lateralis or plasma
1 week
Secondary Outcomes (1)
mRNA or miRNA expression in the vastus lateralis or in peripheral blood
1 week
Study Arms (3)
1
ACTIVE COMPARATORLow dose testosterone
2
ACTIVE COMPARATORHigh dose testosterone
3
PLACEBO COMPARATORPlacebo
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26.
PMID: 21475673RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 22, 2008
Study Start
November 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
January 30, 2015
Record last verified: 2015-01