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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence CD (Numeta G16%E/Organic phosphate) | Experimental |
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| Sequence DC (Organic phosphate/Numeta G16%E) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Numeta G16%E | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-corrected total urinary inorganic phosphate excreted in the urine (Ae(0-24bc)) | Urine PK parameter | Days 1 and 7 |
| Time of maximum observed concentration (T(max)) for inorganic phosphate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erika Ryan, DCN, MS, RD, CDN, CNSC | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin PPD CRU | Austin | Texas | 78744 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 21, 2026 | |
| Reset | Jun 17, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 21, 2026 | Jun 17, 2026 |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C029620 | alpha-glycerophosphoric acid |
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| Sodium Glycerophosphate Injection | Drug | 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. |
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Serum PK parameter
| Days 1, 2, 7, and 8 |
| Apparent terminal elimination half-life (T(1/2 z)) for inorganic phosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| Elimination rate constant (K(z)) for inorganic phosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| Maximum observed concentration (C(max)) for inorganic phosphate | Serum PK parameter | 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 | Days 1, 2, 7, and 8 |
| Total urinary inorganic phosphate excreted in the urine (Ae(0-24)) | Urine PK parameter | Days 1 and 7 |
| Baseline-corrected time of maximum observed concentration (T(maxbc)) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| T(max) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| Baseline-corrected apparent terminal elimination half-life (T(1/2 zbc)) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| T(1/2 z) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| Baseline-corrected elimination rate constant (K(zbc)) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| K(z) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| C(maxbc) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| C(max) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| AUC(0-24bc) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| AUC(0-24) for glycerophosphate | Serum PK parameter | Days 1, 2, 7, and 8 |
| T(maxbc) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| T(max) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| T(1/2 zbc) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| T(1/2 z) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| K(zbc) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| K(z) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| C(maxbc) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| C(max) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| AUC(0-24bc) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| AUC(0-24) for glycerol | Serum PK parameter | Days 1, 2, 7, and 8 |
| Change from baseline in Alanine Aminotransferase (ALT) | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in Alkaline Phosphatase | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in Aspartate Aminotransferase (AST) | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in total bilirubin | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in direct bilirubin | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in eGFR | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in Blood Urea Nitrogen (BUN) | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in creatinine | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in calcium | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in phosphate | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in magnesium | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in potassium | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in sodium | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in respiratory rate | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in heart rate | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in temperature | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Change from baseline in blood pressure | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Number of subjects with any physical examination interpreted as abnormal | Safety outcome | Baseline through Day 11 |
| Number of subjects experiencing any clinically significant abnormality in ECGs | Safety outcome | Baseline, Day 1, Day 2, Day 7, Day 8 |
| Number of subjects experiencing adverse events | Safety outcome | Baseline through Day 20 |