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

Completed · Phase 1

Conditions studied: Parenteral Nutrition

In brief

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).

Key facts

Study ID

NCT06842134

Run by

Baxter Healthcare Corporation

People needed

16

Starts

2025-01-27

Expected to finish

2025-05-22

Last updated by the study team

2025-06-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.
• 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.

Where it is running

• Austin PPD CRU — Austin, Texas, United States

Full record on ClinicalTrials.gov

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