Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Numeta G16%E
Numeta GE · 1 trial · 1 indication
Serum PK parameter
Serum PK parameter
| Arm | Type | Description |
|---|---|---|
| Sequence CD (Numeta G16%E/Organic phosphate) | EXPERIMENTAL | * Period 1: Regimen C (Numeta G16%E) * Period 2: Regimen D (Organic phosphate (sodium glycerophosphate SGP)) |
| Sequence DC (Organic phosphate/Numeta G16%E) | EXPERIMENTAL | * Period 1: Regimen D (Organic phosphate (sodium glycerophosphate SGP)) * Period 2: Regimen C (Numeta G16%E) |
| Name | Type | Description |
|---|---|---|
| Numeta G16%E | DRUG | Numeta G16%E (1000mL) will be given intravenously via peripherally inserted central catheter and will provide an equimolar IV phosphate dose of 8.7 mmol over 9 h. |
| Sodium Glycerophosphate Injection | DRUG | Organic phosphate (SGP) will be diluted 1000mL of sodium chloride (0.9% normal saline) to achieve an equimolar IV phosphate dose of 8.7 mmol over 9 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 ...
Numeta GE is used for parenteral nutrition, a method of delivering essential nutrients intravenously to patients who cannot eat or absorb food normally. It is being evaluated in a Phase 1 clinical program, so it is investigational and not yet approved for commercial use.
Numeta GE is developed by Baxter International Inc., which trades on the New York Stock Exchange under the ticker BAX. Baxter is the sponsor of the clinical program studying the product for parenteral nutrition.
Numeta GE is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA for any indication.
Numeta GE has been studied in one completed Phase 1 trial, NCT06842134, titled A Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E. The trial enrolled 16 healthy adult volunteers in the United States and used a controlled, randomized design without double blinding.
Yes, Numeta GE is also known as Numeta G16%E. The two names refer to the same Baxter International product, which is being studied for parenteral nutrition in a completed Phase 1 trial.