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Clinical Trials/NCT00816712
NCT00816712
Completed
Phase 1

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

Merck Sharp & Dohme LLC0 sites28 target enrollmentStarted: January 2008Last updated:
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ConditionsMuscle Anabolism
DrugsComparator: Testosterone 300 mg, intramuscular injectionComparator: Testosterone 100 mg, Intramuscular injectionComparator: Placebo given by Intramuscular Injection

Overview

Phase
Phase 1
Status
Completed
Enrollment
28
Primary Endpoint
Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
60 Years to 70 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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"

Outcomes

Primary Outcomes

Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.

Time Frame: One week

Secondary Outcomes

  • Variability in the muscle fractional synthetic rate measurements.(One week)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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