A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)

Study Overview
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Brief Summary
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This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).

Official Title
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A Randomized, Single-Blind, Placebo-Controlled, Single-dose, Parallel Design Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (FSR)

Conditions
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Muscle Anabolism

Intervention / Treatment
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* Drug: Comparator: Testosterone 300 mg, intramuscular injection
* Drug: Comparator: Testosterone 100 mg, Intramuscular injection
* Drug: Comparator: Placebo given by Intramuscular Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is weight stable over the past 3 months Patient agrees to refrain from consumption of alcohol from 48 hours prior to entering the study Subject agrees to follow the study restriction of no caffeine while on study Patient agrees to following the meat-free controlled protein weight-maintaining diet Patient is willing to avoid strenuous physical activity Patient has been a nonsmoker for at least 6 months prior to study start Exclusion Criteria: Subject is currently a regular user of any illicit drugs Subject has taken androgenic steroids in the previous 12 months Subject has participated in sports events, resistance exercise training or heavy exercise in the previous month Subject has prostate cancer Subject has a history of cancer except basal-cell tumors Subject has been diagnosed with HIV Subject has been diagnosed with Hepatitis B or C Subject uses certain anti-inflammatory drugs such as ibuprofen, arcoxia or celecoxib Subject uses a blood anticoagulant, such as Coumadin (Warfarin) or high doses of aspirin Subject is currently taking over the counter supplements such as muscle builders or fat burners Subject has an allergy or hypersensitivity to intramuscular testosterone Subject has sciatica Subject has donated blood products or has had phlebotomy within 2 months of signing informed consent Subject has undergone a surgical procedure within 1 month of signing informed consent Subject is currently participating or has participated in a study with an investigational drug or device

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Testosterone - 300 mg IM | Drug: Comparator: Testosterone 300 mg, intramuscular injection<br>* Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies. Day 1 & 7 - Testosterone 300 mg, Intramuscular injection.<br>|
| Active Comparator: B<br>Testosterone - 100 mg IM | Drug: Comparator: Testosterone 100 mg, Intramuscular injection<br>* Day 1 & 7- Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies. Day 1 & 7 - Testosterone 100 mg, Intramuscular injection.<br>|
| Placebo Comparator: C<br>Placebo - IM | Drug: Comparator: Placebo given by Intramuscular Injection<br>* Day 1 & 7 - Infusion with radioactive tracer (dye), given over 12 hours, followed by two thigh muscle needle biopsies. Day 1 & 7 - Placebo given as intramuscular injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone. |  | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability in the muscle fractional synthetic rate measurements. |  | One week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Males with low-normal serum total testosterone levels.