Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glycerophosphate · 1 trial · 1 indication
Serum PK parameter
Serum PK parameter
| Arm | Type | Description |
|---|---|---|
| Sequence AB (Organic phosphate/ Inorganic phosphate) | EXPERIMENTAL | * Period 1: Regimen A (Organic phosphate (sodium glycerophosphate SGP)) * Period 2: Regimen B (Inorganic phosphate (Sodium Phosphates Injection NaP)) |
| Sequence BA (Inorganic phosphate/ Organic phosphate) | EXPERIMENTAL | * Period 1: Regimen B (Inorganic phosphate (Sodium Phosphates Injection NaP)) * Period 2: Regimen A (Organic phosphate (sodium glycerophosphate SGP)) |
| Name | Type | Description |
|---|---|---|
| Sodium Glycerophosphate Injection | DRUG | Organic phosphate (SGP) will be diluted with 500mL of sodium chloride (0.9% normal saline) to achieve an equimolar IV phosphate dose of 60 mmol over 4 hours (h) |
| Sodium Phosphates Injection | DRUG | Inorganic phosphate (NaP) will be diluted with 500mL of sodium chloride (0.9% normal saline) to achieve an equimolar IV phosphate dose of 60 mmol over 4 h |
Inclusion Criteria: 1. Healthy males or non-pregnant, non-lactating healthy females. 2. Aged 18 to 55 years, inclusive, at the time of signing informed consent. 3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 and a minimum body weight of 57 kg as measured at screening. 4. Must be willing and able ...
Glycerophosphate is used for parenteral nutrition, which is the delivery of nutrients directly into the bloodstream. It is being studied as a source of phosphate for patients who require intravenous feeding. The drug is currently in clinical development for this indication.
Glycerophosphate is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. The company is conducting clinical trials to evaluate the drug for use in parenteral nutrition.
Glycerophosphate is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, which studied the drug in healthy volunteers for parenteral nutrition.
Glycerophosphate has one completed clinical trial, identified as NCT06842121. This was a Phase 1 bioequivalence study comparing sodium glycerophosphate injection to sodium phosphates injection in healthy volunteers. The trial enrolled 42 participants and was conducted in the United States.
Glycerophosphate is also known as sodium glycerophosphate. The clinical trial for the drug specifically studied sodium glycerophosphate injection, which is the active form being evaluated for parenteral nutrition. This is the formulation used in the completed Phase 1 study.