NCT00816712

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 60 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Muscle Anabolism

Interventions

Type	Name	Description
DRUG	Comparator: Testosterone 300 mg, intramuscular injection	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.
DRUG	Comparator: Testosterone 100 mg, Intramuscular injection	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.
DRUG	Comparator: Placebo given by Intramuscular Injection	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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2009-01-05
• Last updated: 2015-02-13