drugset / Trial / NCT01962454

A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers

NCT01962454

Phase 1 Completed 20 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindDiagnostic

Summary

This is a single-blind, randomized placebo-controlled, parallel study, where the study volunteers will be blinded to testosterone/placebo treatment. This study will test a relatively new, less invasive method for collecting muscle tissue to determine if this method is appropriate for collecting muscle samples for the assessment of the fractional synthetic rates (FSR) of muscle-derived proteins. This study will also investigate whether the FSR of proteins may serve as early biomarkers for muscle anabolism, a known anabolic agent (testosterone) will be administered to healthy, elderly male subjects over a 3 week period. The fractional synthetic rate of several muscle-derived proteins will be analyzed at Baseline and during the period of testosterone treatment using deuterium labelling of these proteins by the incorporation of deuterium from deuterated water (D2O).

Timeline

Start
2014-05-05
Primary completion
2015-03-20
Completion
2015-03-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Enanthate Small molecule 125 mg Intramuscular
Background Deuterated Water Unknown 50 ml Oral