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

Last updated: April 23, 2025
Sponsor: Baxter Healthcare Corporation
Overall Status: Active - Recruiting

Phase

1

Condition

Diet And Nutrition

Treatment

Numeta G16%E

Sodium Glycerophosphate Injection

Clinical Study ID

NCT06842134
BXU561373 (B)
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy males or non-pregnant, non-lactating healthy females.

  2. Aged 18 to 55 years, inclusive, at the time of signing informed consent.

  3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 and a minimum body weight of 57 kg asmeasured at screening.

  4. Must be willing and able to comply with all study requirements including dietaryrequirements.

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

  6. Must agree to use an adequate method of contraception.

  7. Alkaline phosphatase level within standard reference range/normal limits atscreening and admission.

  8. Serum inorganic phosphate level within standard reference range/normal limits atscreening and admission.

  9. Serum parathyroid hormone (PTH) level within standard reference range/normal limitsat screening.

  10. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levelswithin reference range/normal limits at screening and admission.

Exclusion

Exclusion Criteria:

  1. Subjects who have received any investigational medicinal product (IMP) in a clinicalresearch study within 5 half-lives or within 30 days prior to first dose, whicheveris longer.

  2. Subjects who are study site or Sponsor employees, or subjects who are immediatefamily 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 toscreening. A confirmed positive urine cotinine test at screening or first admission.

  8. Current users of e-cigarettes and nicotine replacement products and those who haveused these products within the last 12 months prior to screening.

  9. Females of childbearing potential must have a negative pregnancy test (urinepregnancy test at screening). Females who are pregnant or lactating will beexcluded.

  10. Have poor venous access that limits phlebotomy.

  11. Clinically significant abnormal clinical chemistry or hematology as judged by theInvestigator.

  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 ofabnormal 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 ECG.

  17. Positive drugs of abuse test result.

  18. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) orhuman immunodeficiency virus (HIV) antibody results.

  19. Evidence of renal impairment at screening, as indicated by an eGFR < 90mL/min/m^2.

  20. History of any active systemic or immunologic disease, including but not limited toactive renal, hepatic, hematological, gastrointestinal (exceptappendectomies/cholecystectomy), endocrinal, pulmonary (including asthma),cardiovascular, neurologic, or neurological disease (including demyelinatingdiseases such as multiple sclerosis), hypertension, tuberculosis, or systemic fungalinfection.

  21. History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.

  22. History of hypophosphatasia.

  23. Serious adverse reaction or serious hypersensitivity to any drug or the formulationexcipients.

  24. Presence or history of clinically significant allergy requiring treatment, as judgedby 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 7days prior to first dose of study medication or had a transfusion of any bloodproduct within 3 months prior to study drug administration.

  27. Subjects who are taking, or have taken, any prescribed or over-the-counter drug orherbal remedies (other than up to 4 g per day acetaminophen and HRT/hormonalcontraception) within the last 30 days or five half-lives (whichever is longer),before IMP administration. Exceptions may apply on a case-by-case basis, ifconsidered not to interfere with the objectives of the study, as determined by theInvestigator.

  28. Subjects who have been administered a drug by depot injection within 30 days priorto the initial study drug administration or 6 half-lives of that drug, whichever islonger and at the discretion of the Investigator or who have received a recent (asdetermined by the Investigator) live or attenuated vaccination (with exception of aCOVID-19 vaccine or flu vaccine), or exposure to communicable viral diseases such aschicken 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 hinderability to adhere to the prescribed diet.

Study Design

Total Participants: 16
Treatment Group(s): 2
Primary Treatment: Numeta G16%E
Phase: 1
Study Start date:
January 27, 2025
Estimated Completion Date:
May 27, 2025

Connect with a study center

  • Austin PPD CRU

    Austin, Texas 78744
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.