ClinicalTrials.gg
Sign In
CompletedNCT06842134Updated Jun 29, 2025

A Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E

A Phase 1 interventional study of Numeta G16%E and Sodium Glycerophosphate Injection in Parenteral Nutrition, sponsored by Baxter Healthcare Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Baxter Healthcare Corporation · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2025, 1 year 5 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Parenteral Nutrition

Keywords

  • organic phosphate
  • inorganic phosphate
  • sodium glycerophosphate
  • pharmacokinetic
  • intravenous
  • parenteral nutrition
03

In context

Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Browse Baxter Healthcare Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy males or non-pregnant, non-lactating healthy females.
  2. Aged 18 to 55 years, inclusive, at the time of signing .
  3. (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 to comply with all study requirements including dietary requirements.
  5. Subject must be literate, has signed a written informed consent form (ICF) and has the ability to communicate and comply with all study requirements
  6. Must agree to use an adequate method of .
  7. Alkaline phosphatase level within standard reference range/normal limits at screening and admission.
  8. Serum inorganic phosphate level within standard reference range/normal limits at screening and admission.
  9. Serum parathyroid hormone (PTH) level within standard reference range/normal limits at screening.
  10. Serum (ALT) and aspartate aminotransferase (AST) levels within reference range/normal limits at screening and admission.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have received any medicinal product (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose, whichever is longer.
  2. Subjects who are study site or Sponsor employees, or subjects who are immediate family members of study site or Sponsor employees.
  3. Subjects who have previously been administered IMP in this study.
  4. History of any drug or alcohol abuse in the past 2 years prior to screening.
  5. Regular alcohol consumption in 6 months prior to screening.
  6. A confirmed positive alcohol urine test at screening or admission.
  7. Current smokers or those who have smoked within the last 12 months prior to screening. A confirmed positive urine cotinine test at screening or first admission.
  8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to screening.
  9. Females of must have a negative pregnancy test (urine pregnancy test at screening). Females who are pregnant or lactating will be excluded.
  10. Have poor venous access that limits phlebotomy.
  11. abnormal clinical chemistry or hematology as judged by the Investigator.
  12. Clinically significant abnormal urinalysis as judged by the Investigator.
  13. History of diabetes mellitus (types I or II).
  14. Prediabetes (fasting blood sugar level of >106 (repeat x 1 for confirmation of abnormal level).
  15. Hypertriglyceridemia (fasting triglyceride level of > 200 mg/dL) at screening.
  16. Subjects who, in the Investigator's opinion, have a clinically significant abnormal 12-lead resting .
  17. Positive drugs of abuse test result.
  18. Positive surface antigen (HBsAg), virus antibody (HCV Ab) or (HIV) antibody results.
  19. Evidence of renal impairment at screening, as indicated by an \< 90mL/min/m\^2.
  20. History of any active systemic or immunologic disease, including but not limited to active renal, hepatic, hematological, gastrointestinal (except appendectomies/cholecystectomy), endocrinal, pulmonary (including asthma), cardiovascular, neurologic, or neurological disease (including demyelinating diseases such as multiple sclerosis), hypertension, tuberculosis, or systemic fungal infection.
  21. History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.
  22. History of hypophosphatasia.
  23. Serious adverse reaction or serious to any drug or the formulation .
  24. Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active.
  25. Significant serious active skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
  26. Donation or loss of 1 pint of blood within 3 months, or donation of plasma within 7 days prior to first dose of study medication or had a transfusion of any blood product within 3 months prior to study drug administration.
  27. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen and HRT/hormonal ) within the last 30 days or five half-lives (whichever is longer), before IMP administration. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as determined by the Investigator.
  28. Subjects who have been administered a drug by depot injection within 30 days prior to the initial study drug administration or 6 half-lives of that drug, whichever is longer and at the discretion of the Investigator or who have received a recent (as determined by the Investigator) live or attenuated vaccination (with exception of a COVID-19 vaccine or flu vaccine), or exposure to communicable viral diseases such as chicken pox, varicella, and measles.
  29. Failure to satisfy the Investigator of fitness to participate for any other reason.
  30. Known hypersensitivity to egg, soya or peanut proteins.
  31. Food allergies deemed clinically relevant by the investigator which would hinder ability to adhere to the prescribed diet.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Sequence CD (Numeta G16%E/Organic phosphate)

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

    Drug: Numeta G16%E · Drug: Sodium Glycerophosphate Injection

  • Experimental
    Sequence DC (Organic phosphate/Numeta G16%E)

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

    Drug: Numeta G16%E · Drug: Sodium Glycerophosphate Injection

Interventions

  • DrugNumeta G16%E

    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.

  • DrugSodium Glycerophosphate Injection

    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.

06

What researchers measure

Primary outcomes

  1. Baseline-corrected maximum observed concentration (C(maxbc)) for inorganic phosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  2. Baseline-corrected area under the curve from time 0 to 24h post-dose (AUC(0-24bc)) for inorganic phosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

Secondary outcomes

  1. Baseline-corrected total urinary inorganic phosphate excreted in the urine (Ae(0-24bc))

    Urine PK parameter

    Time frame: Days 1 and 7

  2. Time of maximum observed concentration (T(max)) for inorganic phosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  3. Apparent terminal elimination half-life (T(1/2 z)) for inorganic phosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  4. Elimination rate constant (K(z)) for inorganic phosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  5. Maximum observed concentration (C(max)) for inorganic phosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  6. Area under the curve from time 0 to 24h post-dose (AUC(0-24)) for inorganic phosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  7. Total urinary inorganic phosphate excreted in the urine (Ae(0-24))

    Urine PK parameter

    Time frame: Days 1 and 7

  8. Baseline-corrected time of maximum observed concentration (T(maxbc)) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  9. T(max) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  10. Baseline-corrected apparent terminal elimination half-life (T(1/2 zbc)) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  11. T(1/2 z) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  12. Baseline-corrected elimination rate constant (K(zbc)) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  13. K(z) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  14. C(maxbc) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  15. C(max) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  16. AUC(0-24bc) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  17. AUC(0-24) for glycerophosphate

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  18. T(maxbc) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  19. T(max) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  20. T(1/2 zbc) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  21. T(1/2 z) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  22. K(zbc) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  23. K(z) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  24. C(maxbc) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  25. C(max) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  26. AUC(0-24bc) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  27. AUC(0-24) for glycerol

    Serum PK parameter

    Time frame: Days 1, 2, 7, and 8

  28. Change from baseline in Alanine Aminotransferase (ALT)

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  29. Change from baseline in Alkaline Phosphatase

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  30. Change from baseline in Aspartate Aminotransferase (AST)

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  31. Change from baseline in total bilirubin

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  32. Change from baseline in direct bilirubin

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  33. Change from baseline in eGFR

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  34. Change from baseline in Blood Urea Nitrogen (BUN)

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  35. Change from baseline in creatinine

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  36. Change from baseline in calcium

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  37. Change from baseline in phosphate

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  38. Change from baseline in magnesium

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  39. Change from baseline in potassium

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  40. Change from baseline in sodium

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  41. Change from baseline in respiratory rate

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  42. Change from baseline in heart rate

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  43. Change from baseline in temperature

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  44. Change from baseline in blood pressure

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  45. Number of subjects with any physical examination interpreted as abnormal

    Safety outcome

    Time frame: Baseline through Day 11

  46. Number of subjects experiencing any clinically significant abnormality in ECGs

    Safety outcome

    Time frame: Baseline, Day 1, Day 2, Day 7, Day 8

  47. Number of subjects experiencing adverse events

    Safety outcome

    Time frame: Baseline through Day 20

07

Study locations

1 site
  • Austin PPD CRU
    Austin, Texas 78744, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2025 to primary completion in May 2025, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2025
First posted
Feb 24, 2025
StartActual
Jan 27, 2025
Primary completionActual
May 22, 2025
CompletionActual
May 22, 2025
Last update
Jun 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06842134
Lead sponsor
Baxter Healthcare Corporation
Responsible party
Sponsor
First posted
Feb 24, 2025
Start date
Jan 27, 2025
Primary completion
May 22, 2025
Completion
May 22, 2025
Last update
Jun 29, 2025

Study contacts

Erika Ryan, DCN, MS, RD, CDN, CNSC
study director · Baxter Healthcare Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Alpha-glycerophosphoric acid

Other studies from this sponsor

Baxter Healthcare Corporation →

Start the discussion