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Deuterated Water · 1 trial · 1 indication
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...
Deuterated Water is an investigational small molecule being studied for cachexia, a condition of severe weight loss and muscle wasting. It is in Phase 1 clinical development. The drug is being evaluated in a clinical trial that includes healthy male volunteers aged 60 years and older.
Deuterated Water is being developed by GSK plc, a biopharmaceutical company. GSK's ticker symbol is GSK. The drug is currently in Phase 1 clinical development for cachexia.
Deuterated Water is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not yet available for clinical use.
Deuterated Water has one completed clinical trial, NCT01962454, titled "A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers." The trial enrolled 20 participants in the United States and was placebo-controlled.
Deuterated Water is a form of water in which the hydrogen atoms are replaced by deuterium, a heavier isotope of hydrogen. It is sometimes referred to as heavy water. In the context of this clinical development, it is being studied for its potential effects on cachexia.