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

Phase 1
Completed
Conditions
Muscle Anabolism
Registration Number
NCT00816712
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
28
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.One week
Secondary Outcome Measures
NameTimeMethod
Variability in the muscle fractional synthetic rate measurements.One week
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