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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
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.
Austin PPD CRU
Austin, Texas, United States
Baseline-corrected maximum observed concentration (C(maxbc)) for inorganic phosphate
Serum PK parameter
Time frame: 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
Time frame: Days 1, 2, 7, and 8
Baseline-corrected total urinary inorganic phosphate excreted in the urine (Ae(0-24bc))
Urine PK parameter
Time frame: Days 1 and 7
Time of maximum observed concentration (T(max)) for inorganic phosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
Apparent terminal elimination half-life (T(1/2 z)) for inorganic phosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
Elimination rate constant (K(z)) for inorganic phosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
Maximum observed concentration (C(max)) for inorganic phosphate
Serum PK parameter
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
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total urinary inorganic phosphate excreted in the urine (Ae(0-24))
Urine PK parameter
Time frame: Days 1 and 7
Baseline-corrected time of maximum observed concentration (T(maxbc)) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
T(max) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
Baseline-corrected apparent terminal elimination half-life (T(1/2 zbc)) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
T(1/2 z) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
Baseline-corrected elimination rate constant (K(zbc)) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
K(z) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
C(maxbc) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
C(max) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
AUC(0-24bc) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
AUC(0-24) for glycerophosphate
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
T(maxbc) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
T(max) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
T(1/2 zbc) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
T(1/2 z) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
K(zbc) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
K(z) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
C(maxbc) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
C(max) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
AUC(0-24bc) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
AUC(0-24) for glycerol
Serum PK parameter
Time frame: Days 1, 2, 7, and 8
Change from baseline in Alanine Aminotransferase (ALT)
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in Alkaline Phosphatase
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in Aspartate Aminotransferase (AST)
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in total bilirubin
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in direct bilirubin
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in eGFR
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in Blood Urea Nitrogen (BUN)
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in creatinine
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in calcium
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in phosphate
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in magnesium
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in potassium
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in sodium
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in respiratory rate
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in heart rate
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in temperature
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Change from baseline in blood pressure
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Number of subjects with any physical examination interpreted as abnormal
Safety outcome
Time frame: Baseline through Day 11
Number of subjects experiencing any clinically significant abnormality in ECGs
Safety outcome
Time frame: Baseline, Day 1, Day 2, Day 7, Day 8
Number of subjects experiencing adverse events
Safety outcome
Time frame: Baseline through Day 20