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NCT01962454 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01962454 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 20 participants.
The verdict
NCT01962454, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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).
Interventions
- DRUG Testosterone enanthate
- DRUG Deuterated Water
- DRUG Placebo to match testosterone enanthate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-05-05 |
| Est. Completion | 2015-03-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01962454
The ClinicalTrials.gov registry entry for NCT01962454 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Testosterone enanthate is the first listed.
NCT01962454 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01962454 about?
NCT01962454 is a clinical study titled "A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers". 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 musc...
What is the current status of trial NCT01962454?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-05-05. Estimated completion is 2015-03-20.
What interventions are being tested in trial NCT01962454?
The interventions under investigation include: Testosterone enanthate (DRUG), Deuterated Water (DRUG), Placebo to match testosterone enanthate (DRUG).
Who is sponsoring clinical trial NCT01962454?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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