Parenteral NutritionPhase 1NCT06842121
A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP)
A Phase 1 study testing Sodium Glycerophosphate Injection and Sodium Phosphates Injection in people with Parenteral Nutrition, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
This is a phase 1, prospective, single-center, randomized sequence, double-blind, 2-way crossover, relative bioavailability study in healthy adult subjects comparing Sodium Glycerophosphate Injection (SGP) to Sodium Phosphate Injection (NaP). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- Sodium Glycerophosphate Injection and Sodium Phosphates Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2025to 22 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating healthy females.
- Aged 18 to 55 years, inclusive, at the time of signing informed consent.
- 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.
- Must be willing and able to comply with all study requirements including dietary requirements.
- 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.
Show all 10Show fewer
- Alkaline phosphatase level within standard reference range/normal limits at screening and admission.
- Serum inorganic phosphate level within standard reference range/normal limits at screening and admission.
- Serum parathyroid hormone (PTH) level within standard reference range/normal limits at screening.
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within reference range/normal limits at screening and admission.
Who cannot join
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose, whichever is longer.
- 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.
- History of any drug or alcohol abuse in the past 2 years prior to screening.
- Regular alcohol consumption in 6 months prior to screening.
- A confirmed positive alcohol urine test at screening or admission.
Show all 31Show fewer
- 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.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to screening.
- Females of childbearing potential must have a negative pregnancy test (urine pregnancy test at screening). Females who are pregnant or lactating will be excluded.
- Have poor venous access that limits phlebotomy.
- Clinically significant abnormal clinical chemistry or hematology as judged by the Investigator.
- Clinically significant abnormal urinalysis as judged by the Investigator.
- History of diabetes mellitus (types I or II).
- Prediabetes (fasting blood sugar level of >106 (repeat x 1 for confirmation of abnormal level).
- Hypertriglyceridemia (fasting triglyceride level of > 200 mg/dL) at screening.
- Subjects who, in the Investigator's opinion, have a clinically significant abnormal 12-lead resting ECG.
- Positive drugs of abuse test result.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
- Evidence of renal impairment at screening, as indicated by an eGFR < 90mL/min/m^2.
- 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.
- History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.
- History of hypophosphatasia.
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active.
- Significant serious active skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
- 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.
- 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 contraception) 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.
- 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.
- Failure to satisfy the Investigator of fitness to participate for any other reason.
- Known hypersensitivity to egg, soy or peanut proteins.
- Food allergies deemed clinically relevant by the investigator which would hinder ability to adhere to the prescribed diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Prospective, Single-Center, Randomized Sequence, Double-Blind, 2-Way Crossover Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP)
This is a phase 1, prospective, single-center, randomized sequence, double-blind, 2-way crossover, relative bioavailability study in healthy adult subjects comparing Sodium Glycerophosphate Injection (SGP) to Sodium Phosphate Injection (NaP).
In this study it is planned to randomize approximately 42 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).
- Conditions
- Parenteral Nutrition
- Being tested
- Sodium Glycerophosphate Injection, Sodium Phosphates Injection
- Keywords
- organic phosphate, inorganic phosphate, sodium glycerophosphate, pharmacokinetic, intravenous, parenteral nutrition
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Glycerophosphate InjectionDrug
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 InjectionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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)) Receives: Drug: Sodium Glycerophosphate Injection; Drug: Sodium Phosphates Injection |
| 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)) Receives: Drug: Sodium Glycerophosphate Injection; Drug: Sodium Phosphates Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-corrected maximum observed concentration (C(maxbc)) for inorganic phosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Baseline-corrected area under the curve from time 0 to 24h post-dose (AUC(0-24bc)) for inorganic phosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Secondary outcomes (49)
Baseline-corrected total urinary inorganic phosphate excreted in the urine (Ae(0-24bc))
Urine PK parameter
Measured: Days 1 and 7
Time of maximum observed concentration (T(max)) for inorganic phosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Apparent terminal elimination half-life (T(1/2 z)) for inorganic phosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Elimination rate constant (K(z)) for inorganic phosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Maximum observed concentration (C(max)) for inorganic phosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Area under the curve from time 0 to 24h post-dose (AUC(0-24)) for inorganic phosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Total urinary inorganic phosphate excreted in the urine (Ae(0-24))
Urine PK parameter
Measured: Days 1 and 7
Baseline-corrected time of maximum observed concentration (T(maxbc)) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
T(max) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Baseline-corrected apparent terminal elimination half-life (T(1/2 zbc)) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
T(1/2 z) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Baseline-corrected elimination rate constant (K(zbc)) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
K(z) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
C(maxbc) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
C(max) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
AUC(0-24bc) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
AUC(0-24) for glycerophosphate
Serum PK parameter
Measured: Days 1, 2, 7, and 8
T(maxbc) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
T(max) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
T(1/2 zbc) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
T(1/2 z) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
K(zbc) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
K(z) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
C(maxbc) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
C(max) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
AUC(0-24bc) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
AUC(0-24) for glycerol
Serum PK parameter
Measured: Days 1, 2, 7, and 8
Change from baseline in Alanine Aminotransferase (ALT)
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in Alkaline Phosphatase
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in Aspartate Aminotransferase (AST)
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in total bilirubin
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in direct bilirubin
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in eGFR
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in Blood Urea Nitrogen (BUN)
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in creatinine
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in calcium
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in phosphate
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in magnesium
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in potassium
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in sodium
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in ionized calcium
Safety outcome
Measured: Day 1, Day 7
Change from baseline in respiratory rate
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in heart rate
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in temperature
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in blood pressure
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Number of subjects with any physical examination interpreted as abnormal
Safety outcome
Measured: Baseline through Day 11
Number of subjects experiencing any clinically significant abnormality in telemetry
Safety outcome
Measured: Day 1, Day 7
Number of subjects experiencing any clinically significant abnormality in ECGs
Safety outcome
Measured: Baseline, Day 1, Day 2, Day 7, Day 8
Number of subjects experiencing adverse events
Safety outcome
Measured: Baseline through Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start27 Jan 2025
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erika Ryan, DCN, MS, RD, CDN, CNSC, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842121
- Sponsor's protocol ID
- BXU561373
- Status last verified
- Jun 2025
- First submitted
- 11 Feb 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Prospective, Single-Center, Randomized Sequence, Double-Blind, 2-Way Crossover Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP)
- ClinicalTrials.gov ID
- NCT06842121
- Acronym / sponsor ID
- BXU561373
- Conditions
- Parenteral Nutrition
- Keywords
- organic phosphate, inorganic phosphate, sodium glycerophosphate, pharmacokinetic, intravenous, parenteral nutrition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, prospective, single-center, randomized sequence, double-blind, 2-way crossover, relative bioavailability study in healthy adult subjects comparing Sodium Glycerophosphate Injection (SGP) to Sodium Phosphate Injection (NaP).
In this study it is planned to randomize approximately 42 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB (Organic phosphate/ Inorganic phosphate) | Experimental | Drug: Sodium Glycerophosphate Injection, Drug: Sodium Phosphates Injection* 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 | Drug: Sodium Glycerophosphate Injection, Drug: Sodium Phosphates Injection* Period 1: Regimen B (Inorganic phosphate (Sodium Phosphates Injection NaP)) * Period 2: Regimen A (Organic phosphate (sodium glycerophosphate SGP)) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy males or non-pregnant, non-lactating healthy females.
- Aged 18 to 55 years, inclusive, at the time of signing informed consent.
- 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.
- Must be willing and able to comply with all study requirements including dietary requirements.
- Subject must be literate, has signed a written informed consent form (ICF) and has the ability to communicate and comply with all study requirements
Key exclusion criteria (31 listed)
- Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose, whichever is longer.
- 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.
- History of any drug or alcohol abuse in the past 2 years prior to screening.
- Regular alcohol consumption in 6 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Glycerophosphate InjectionOrganic 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) | Drug | Sequence AB (Organic phosphate/ Inorganic phosphate), Sequence BA (Inorganic phosphate/ Organic phosphate) |
| Sodium Phosphates InjectionInorganic 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 | Drug | Sequence AB (Organic phosphate/ Inorganic phosphate), Sequence BA (Inorganic phosphate/ Organic phosphate) |
Primary outcome
Baseline-corrected maximum observed concentration (C(maxbc)) for inorganic phosphate
Time frame: Days 1, 2, 7, and 8
Serum PK parameter
Baseline-corrected area under the curve from time 0 to 24h post-dose (AUC(0-24bc)) for inorganic phosphate
Time frame: Days 1, 2, 7, and 8
Serum PK parameter
49 secondary outcomes
Baseline-corrected total urinary inorganic phosphate excreted in the urine (Ae(0-24bc))
Time frame: Days 1 and 7
Time of maximum observed concentration (T(max)) for inorganic phosphate
Time frame: Days 1, 2, 7, and 8
Apparent terminal elimination half-life (T(1/2 z)) for inorganic phosphate
Time frame: Days 1, 2, 7, and 8
Elimination rate constant (K(z)) for inorganic phosphate
Time frame: Days 1, 2, 7, and 8
Maximum observed concentration (C(max)) for inorganic phosphate
Time frame: Days 1, 2, 7, and 8
Area under the curve from time 0 to 24h post-dose (AUC(0-24)) for inorganic phosphate
Time frame: Days 1, 2, 7, and 8
Total urinary inorganic phosphate excreted in the urine (Ae(0-24))
Time frame: Days 1 and 7
Baseline-corrected time of maximum observed concentration (T(maxbc)) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
T(max) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
Baseline-corrected apparent terminal elimination half-life (T(1/2 zbc)) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
T(1/2 z) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
Baseline-corrected elimination rate constant (K(zbc)) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
K(z) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
C(maxbc) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
C(max) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
AUC(0-24bc) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
AUC(0-24) for glycerophosphate
Time frame: Days 1, 2, 7, and 8
T(maxbc) for glycerol
Time frame: Days 1, 2, 7, and 8
T(max) for glycerol
Time frame: Days 1, 2, 7, and 8
T(1/2 zbc) for glycerol
Time frame: Days 1, 2, 7, and 8
T(1/2 z) for glycerol
Time frame: Days 1, 2, 7, and 8
K(zbc) for glycerol
Time frame: Days 1, 2, 7, and 8
K(z) for glycerol
Time frame: Days 1, 2, 7, and 8
C(maxbc) for glycerol
Time frame: Days 1, 2, 7, and 8
C(max) for glycerol
Time frame: Days 1, 2, 7, and 8
AUC(0-24bc) for glycerol
Time frame: Days 1, 2, 7, and 8
AUC(0-24) for glycerol
Time frame: Days 1, 2, 7, and 8
Change from baseline in Alanine Aminotransferase (ALT)
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in Alkaline Phosphatase
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in Aspartate Aminotransferase (AST)
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in total bilirubin
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in direct bilirubin
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in eGFR
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in Blood Urea Nitrogen (BUN)
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in creatinine
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in calcium
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in phosphate
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in magnesium
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in potassium
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in sodium
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Ryan, DCN, MS, RD, CDN, CNSC study director
Baxter Healthcare Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Glycerophosphate Injection and Sodium Phosphates Injection in people with Parenteral Nutrition, run by Baxter Healthcare Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline-corrected maximum observed concentration (C(maxbc)) for inorganic phosphate (time frame: Days 1, 2, 7, and 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.