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NCT01962454
A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers
Phase 1 trial testing Deuterated Water in Cachexia in 20 participants. Completed in 20 March 2015.
20 March 2015
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 20 |
| Start date | 5 May 2014 |
| Primary completion | 20 March 2015 |
| Estimated completion | 20 March 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Deuterated Water — full drug profile →
- Testosterone enanthate — full drug profile →
- Placebo to match testosterone enanthate — full drug profile →
Conditions studied
- Cachexia — all drugs for Cachexia →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 60 to 75, male only, with Cachexia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Androgens as the "old age stick" in skeletal muscle.
Gentile G, De Stefano F, Sorrentino C, D'Angiolo R, et al · · 2025 · cited 7× · PMID 40181329 · DOI 10.1186/s12964-025-02163-6
Verify or expand the search:
- PubMed search for NCT01962454
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other GlaxoSmithKline trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01962454 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 9 May 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01962454.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing