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Completed

NCT Number: NCT00816712

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

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

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Key information

Conditions

Muscle Anabolism

Age range

60 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: Testosterone 300 mg, intramuscular injection

Drug

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.

Comparator: Testosterone 100 mg, Intramuscular injection

Drug

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.

Comparator: Placebo given by Intramuscular Injection

Drug

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.

Primary outcomes

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

    Time frame: One week

Secondary outcomes

  1. Variability in the muscle fractional synthetic rate measurements.

    Time frame: One week

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 5, 2009
Registry last updated
Feb 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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