A Bioequivalence Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Inorganic Phosphate (Sodium Phosphates Injection, USP)

NCT06842121 | Completed Phase 1 FDA Drug

• 1 other identifier: BXU561373
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

organic phosphate; inorganic phosphate; sodium glycerophosphate; pharmacokinetic; intravenous; parenteral nutrition

Outcome Measures

Primary Outcomes (2)

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

  Serum PK parameter

  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

  Days 1, 2, 7, and 8

Secondary Outcomes (49)

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

  Days 1 and 7

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

  Days 1, 2, 7, and 8

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

  Days 1, 2, 7, and 8

• Elimination rate constant (K(z)) for inorganic phosphate

  Days 1, 2, 7, and 8

• Maximum observed concentration (C(max)) for inorganic phosphate

  Days 1, 2, 7, and 8

Study Arms (2)

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))

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))

Drug: Sodium Glycerophosphate Injection; Drug: Sodium Phosphates Injection

Interventions

Sodium Glycerophosphate Injection DRUG

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)

Sequence AB (Organic phosphate/ Inorganic phosphate); Sequence BA (Inorganic phosphate/ Organic phosphate)

Sodium Phosphates Injection DRUG

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

Sequence AB (Organic phosphate/ Inorganic phosphate); Sequence BA (Inorganic phosphate/ Organic phosphate)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (1)

Austin PPD CRU

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Hyperphagia

Interventions

alpha-glycerophosphoric acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erika Ryan, DCN, MS, RD, CDN, CNSC

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 24, 2025
• Study Start: January 27, 2025
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)