Biomarkers of Muscle Anabolism (MK-0000-082)

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

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

Conditions
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Muscle Anabolism

Intervention / Treatment
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* Drug: Comparator: low dose testosterone
* Drug: Comparator: high dose testosterone
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Low dose testosterone | Drug: Comparator: low dose testosterone<br>* 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.<br>|
| Active Comparator: 2<br>High dose testosterone | Drug: Comparator: high dose testosterone<br>* 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.<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Comparator: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparative proteomics on proteins present in the vastus lateralis or plasma |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRNA or miRNA expression in the vastus lateralis or in peripheral blood |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers of muscle anabolism