Muscle Anabolism
Conditions
Keywords
Biomarkers of muscle anabolism
Brief summary
This study will evaluate the ability of comparative proteomics to identify early biomarkers of muscle anabolism.
Interventions
DRUGComparator: low dose testosterone
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.
DRUGComparator: high dose 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.
DRUGComparator: placebo
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparative proteomics on proteins present in the vastus lateralis or plasma | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| mRNA or miRNA expression in the vastus lateralis or in peripheral blood | 1 week |
Outcome results
None listed