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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
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)
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
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
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 ionized calcium
Safety outcome
Time frame: Day 1, Day 7
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 telemetry
Safety outcome
Time frame: Day 1, Day 7
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
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