Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01962454 | A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers | PHASE1 | COMPLETED | 20 | — | — | May 5, 2014 | Mar 20, 2015 | May 9, 2017 | 1 | United States |
Muscle protein synthesis will be assessed by measuring the fractional synthetic rate of muscle-derived proteins in both muscle biopsy samples and in blood after subjects have ingested deuterated water. The FSR 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 D2O.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Run-in Phase: All participants will receive oral deuterated water (D2O) for 3 weeks prior to the Treatment Phase of the study. The participants will consume 50mL 70% D2O three times per day (TID) for 7 days, followed by a 50ml 70% D2O dose twice daily (BID) for the next 2 weeks. Treatment Phase: Subjects will receive testosterone matching placebo IM injection one per week and 50 mL 70% D2O dose BID for 3 weeks. |
| Arm 2 | PLACEBO_COMPARATOR | Run-in Phase: All participants will receive oral D2O for 3 weeks prior to the Treatment Phase of the study. The participants will consume 50 mL 70% D2O TID for 7 days, followed by a 50mL 70% D2O dose BID for the next 2 weeks. Treatment Phase: Subjects will receive testosterone IM injection one per week and 50 mL 70% D2O dose BID for 3 weeks |
| Name | Type | Description |
|---|---|---|
| Deuterated Water | DRUG | D2O 70% will be supplied as clear liquid, provided in 50 millilitre (mL) unit dose vials; administered per orally. |
| Testosterone enanthate | DRUG | Testosterone enanthate 125mg injection will be supplied as colorless to pale yellow liquid; administered intramuscular (IM). |
| Placebo to match testosterone enanthate | DRUG | Placebo to match testosterone enanthate 0.625 mL injection will be supplied as greenish yellow, bright and clear oily liquid; administered intramuscular (IM). |
Inclusion Criteria: * Males aged between 60-75 of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A...