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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different intravenous nutrition treatments to compare their effectiveness. The goal is to evaluate how Numeta G16%E performs against Sodium Glycerophosphate Injection in delivering essential nutrients through an IV. Researchers seek healthy individuals willing to stay at the study location for 11 days. Ideal candidates should not have chronic illnesses or a history of substance use. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have used Numeta G16%E for intravenous feeding in newborns and young children. It has generally been well-tolerated, but doctors closely monitor patients. Light can affect the solution, so special care is necessary during use.

Sodium Glycerophosphate has also been safely used for intravenous feeding. Research has shown that even high doses are well-tolerated, with no reported overdose effects. Most patients handle it without problems.

Since this trial is in the early stages, the main goal is to assess safety in healthy adults. Early-stage trials often focus on safety, with participants monitored to ensure no unexpected effects occur. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore innovative ways to deliver intravenous nutrition. Numeta G16%E is unique because it provides a balanced nutrient mix in a single, pre-prepared solution, minimizing the risk of compounding errors and saving time. Sodium glycerophosphate, on the other hand, serves as an organic phosphate source, potentially enhancing phosphate bioavailability compared to traditional inorganic options. These approaches could lead to more efficient nutrient delivery and better patient outcomes in clinical settings.

What evidence suggests that this trial's treatments could be effective?

This trial will compare Numeta G16%E with Sodium Glycerophosphate Injection for intravenous nutrition. Research has shown that Numeta G16%E effectively provides nutrition through an IV for patients unable to eat or digest food normally. It supports the nutritional needs of infants and young children, aiding their growth and development. Numeta G16%E also aims to lower the risk of mistakes and infections compared to other nutritional methods.

Sodium Glycerophosphate Injection, on the other hand, supplies higher levels of calcium and phosphate, essential for bone health and overall nutrition. Studies indicate that Sodium Glycerophosphate helps maintain better levels of these nutrients in the blood, which is crucial for patients requiring IV nutrition. Both treatments in this trial aim to improve nutrition when eating is not possible. ^{1 3 5 6 7}

Who Is on the Research Team?

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

Principal Investigator

Baxter Healthcare Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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 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]

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 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]

Citations

1. emeaclinicalnutrition.baxter.com emeaclinicalnutrition.baxter.com/numeta

Numeta - Clinical Nutrition EMEA Numeta may help reduce the risk of compounding errors, bloodstream infections, and medication errors that are seen with compounded PN.4-5. See full prescribing ...

2. ema.europa.eu ema.europa.eu/en/medicines/human/referrals/numeta-g13e-numeta-g16e-emulsion-infusion

Numeta G13%E and Numeta G16%E emulsion for infusion For Numeta G16%E: The benefit-risk balance of the nutrition preparation Numeta G16%E, used in full-term newborns and children up to two years, remains positive ...

3. clinicalnutrition.baxterhealthcare.co.uk clinicalnutrition.baxterhealthcare.co.uk/numeta

Numeta - Advancing Clinical Nutrition A retrospective study found that Numeta G13%E Preterm was associated with improved nutrient intakes and postnatal growth in very low-birthweight (VLBW) infants.

4. docetp.mpa.se docetp.mpa.se/LMF/Numeta%20G16E%20and%20Numeta%20G19E%20%20emulsion%20for%20infusion%20ENG%20PAR_09001bee807a5df3.pdf

Numeta G16E and Numeta G19E emulsion for infusion ... Numeta is indicated for i.v. parenteral nutrition in the pediatric population when oral or enteral nutrition is impossible, insufficient or ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06842134?term=AREA%5BBasicSearch%5D(PRELIEF)&rank=4

A Study Comparing Organic Phosphate (Sodium ... 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 ...

6. medicines.org.uk medicines.org.uk/emc/files/pil.7398.pdf

Information for the user Numeta G16%E emulsion for infusion Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects ...

7. emeanutritionlibrary.baxter.com emeanutritionlibrary.baxter.com/sites/g/files/ebysai3251/files/2021-06/Stability%20and%20Compatibility%20Booklet%20-%20%20Numeta%20G16.pdf

NUMETA G16E - Clinical Nutrition EMEA Fertility, Pregnancy and lactation: Pregnancy:No safety data are available for CERNEVIT administered during pregnancy or in breastfeeding women. This ...