Numeta G16%E vs Sodium Glycerophosphate for Intravenous Nutrition

Overseen By Clinical Research Manager

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Baxter Healthcare Corporation

Must not be taking: Antidepressants, Antipsychotics, others

Disqualifiers: Diabetes, Hypertension, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 11 days

16 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed or over-the-counter drugs or herbal remedies (except for up to 4 g per day of acetaminophen and hormonal contraception) within the last 30 days or five half-lives before the study medication is given. Exceptions may be made on a case-by-case basis if the investigator determines they won't interfere with the study.

Is sodium glycerophosphate safe for use in humans?

Research indicates that sodium glycerophosphate is generally safe for use in humans, as it has a similar safety profile to inorganic phosphate when used in intravenous nutrition. ^{1 2 3 4 5}

How does the drug Numeta G16%E differ from other treatments for intravenous nutrition?

Numeta G16%E is unique because it combines glycerol, a nonprotein calorie source, with amino acids for intravenous nutrition, which can improve nitrogen balance and is safe for peripheral vein administration. This differs from other treatments that may not use glycerol or require central line administration. ^{3 6 7 8 9}

What is the purpose of this trial?

This is a phase 1, prospective, single-center, randomized sequence, open label, 2-way crossover study comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E. It is planned to randomize approximately 16 healthy male and female subjects. All study periods will be completed during a single residency, the overall duration of residency will be 11 days (10 nights).

Research Team

Erika Ryan, DCN, MS, RD, CDN, CNSC

Principal Investigator

Baxter Healthcare Corporation

Eligibility Criteria

This trial is for about 16 healthy men and women. It's not clear who can't join because the exclusion criteria are missing, but typically people with certain health conditions or taking conflicting medications would be excluded.

Inclusion Criteria

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

Subject must be literate, has signed a written informed consent form (ICF) and has the ability to communicate and comply with all study requirements

Must agree to use an adequate method of contraception

Exclusion Criteria

I haven't taken any experimental drugs recently.

Subjects who are study site or Sponsor employees, or subjects who are immediate family members of study site or Sponsor employees

Subjects who have previously been administered IMP in this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 2-way crossover study with Organic Phosphate and Numeta G16%E during a single residency

11 days

Continuous residency

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 days

Treatment Details

Interventions

• Numeta G16%E
• Sodium Glycerophosphate Injection

Trial Overview The study is testing two types of intravenous nutrition: Organic Phosphate (Sodium Glycerophosphate Injection) versus Numeta G16%E. Participants will try both in a random order during an 11-day stay at the facility.

Participant Groups

Group I: Sequence DC (Organic phosphate/Numeta G16%E) Experimental Treatment 2 Interventions

* Period 1: Regimen D (Organic phosphate (sodium glycerophosphate SGP)) * Period 2: Regimen C (Numeta G16%E)

Group II: Sequence CD (Numeta G16%E/Organic phosphate) Experimental Treatment 2 Interventions

* Period 1: Regimen C (Numeta G16%E) * Period 2: Regimen D (Organic phosphate (sodium glycerophosphate SGP))

Who Is Running the Clinical Trial?

Baxter Healthcare Corporation

Lead Sponsor

Trials

328

Recruited

203,000+

Dr. Heather Knight

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Findings from Research

In a study of 172 extremely low birth weight infants, replacing potassium phosphate (K3PO4) with sodium glycerophosphate (NaGP) in parenteral nutrition significantly increased calcium and phosphorus intake, leading to improved serum levels of these minerals after 14 days.

The use of NaGP was associated with lower rates of electrolyte imbalances and clinical issues such as hypophosphatemia and bronchopulmonary dysplasia, particularly in infants who required prolonged parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium Glycerophosphate Use in Parenteral Nutrition Improves Mineral Metabolism in Extremely Low Birth Weight Infants. Hsu, PC., Tsao, PN., Chou, HC., et al.[2023]

In a case study, a patient on parenteral nutrition developed hypophosphatemia, highlighting the need for effective phosphate repletion methods when standard parenteral supplements are unavailable.

Using diluted hypertonic sodium phosphate enemas proved to be an effective and cost-efficient alternative for restoring phosphate levels, as phosphate is easily absorbed through the rectal mucosa, potentially preventing serious complications in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel phosphorus repletion strategy in a patient with duodenal perforation. Kemmerly, T., Vuong, C., Kaunitz, JD.[2022]

Two patients with advanced tumors experienced severe adverse reactions after receiving parenteral nutrition containing fat emulsion (10%)/amino acids (15)/glucose (20%), highlighting potential safety concerns with this nutritional support.

Despite the adverse reactions, symptoms were relieved upon stopping the infusion, and the patients did not experience similar side effects upon re-administration, suggesting that careful monitoring and individualized administration plans are crucial for safe use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe side effects caused by parenteral nutrition therapy with fat emulsion (10%)/amino acids (15)/glucose (20%) injection: 2 case reports. Jia, H., Sun, Y., Hou, F., et al.[2022]

In a study involving 27 healthy volunteers, sodium glycerophosphate and sodium phosphate showed nearly identical pharmacokinetic profiles for inorganic phosphate in serum after intravenous administration, indicating they are essentially similar in how they behave in the body.

Both treatments were found to be safe, with only mild to moderate adverse events reported, and no serious adverse events occurred, suggesting good tolerability for both drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycerophosphate is interchangeable with inorganic phosphate in terms of safety and serum pharmacokinetics. Topp, H., Hochfeld, O., Bark, S., et al.[2013]

In a study of seven different parenteral nutrition solutions, precipitates were found in all formulations containing calcium and phosphorus, indicating potential safety concerns when administering these solutions.

Although no calcium phosphate precipitates were detected within the consensus limits, the presence of micro precipitates with calcium suggests that filtering parenteral nutrition solutions before administration is crucial to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Precipitation limits in pediatric parenteral nutritions with organic sources of calcium and phosphate]. Lázaro Cebas, A., Pablos Bravo, S., Gomis Muñoz, P., et al.[2019]

Intravenous fat emulsions, specifically soybean oil in glycerol, can effectively spare nitrogen in the body when no nitrogen intake is present, suggesting they are a viable alternative to glucose solutions in parenteral nutrition.

The protein conservation effect achieved by the fat emulsion can also be replicated by infusing glycerol alone, indicating that glycerol plays a key role in this nitrogen-sparing mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycerol: major contributor to the short term protein sparing effect of fat emulsions in normal man. Brennan, MF., Fitzpatrick, GF., Cohen, KH., et al.[2019]

Glycerol esters of short and medium chain fatty acids show promise as a nutritional therapy, providing a combination of carbohydrates and fats that can effectively supply energy to various tissues.

Experimental studies in rats and dogs indicate that these compounds are rapidly broken down in the body and can serve as an energy source comparable to glucose, with no observed toxicity, suggesting they are safe for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New synthetic substrates for parenteral feeding. Birkhahn, RH., Long, CL., Blakemore, WS.[2017]

A study involving fasting patients undergoing major abdominal surgery showed that adding glycerol to a 3% amino acid solution for peripheral parenteral nutrition significantly improved nitrogen balance compared to amino acids alone, with a cumulative nitrogen balance of +5 gm versus -9.7 gm (P < 0.02).

The combination of amino acids and glycerol was found to be safe, with no adverse reactions reported, and it maintained similar liver function and electrolyte levels compared to the amino acids-only group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of glycerol in peripheral parenteral nutrition. Fairfull-Smith, RJ., Stoski, D., Freeman, JB.[2013]

A new method for creating fine emulsified fat particles for intravenous nutrition was developed, achieving particle sizes below 250 nm with a 50% oil phase ratio, which is crucial for stability and effectiveness.

The emulsions demonstrated stability over 3 months at 40 degrees Celsius, indicating their potential as a reliable caloric source for peripheral parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of fine emulsified fat particles without glycerol for intravenous nutrition. Arii, K., Fukuta, Y., Kai, T., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sodium Glycerophosphate Use in Parenteral Nutrition Improves Mineral Metabolism in Extremely Low Birth Weight Infants. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A novel phosphorus repletion strategy in a patient with duodenal perforation. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Severe side effects caused by parenteral nutrition therapy with fat emulsion (10%)/amino acids (15)/glucose (20%) injection: 2 case reports. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Glycerophosphate is interchangeable with inorganic phosphate in terms of safety and serum pharmacokinetics. [2013]

5. Spain pubmed.ncbi.nlm.nih.gov

[Precipitation limits in pediatric parenteral nutritions with organic sources of calcium and phosphate]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Glycerol: major contributor to the short term protein sparing effect of fat emulsions in normal man. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

New synthetic substrates for parenteral feeding. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Use of glycerol in peripheral parenteral nutrition. [2013]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Preparation of fine emulsified fat particles without glycerol for intravenous nutrition. [2019]