Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06842134 | A Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E | PHASE1 | COMPLETED | 16 | — | — | Jan 27, 2025 | May 22, 2025 | Jun 29, 2025 | 1 | United States |
Serum PK parameter
Serum PK parameter
| Arm | Type | Description |
|---|---|---|
| Sequence CD (Numeta G16%E/Organic phosphate) | EXPERIMENTAL | * Period 1: Regimen C (Numeta G16%E) * Period 2: Regimen D (Organic phosphate (sodium glycerophosphate SGP)) |
| Sequence DC (Organic phosphate/Numeta G16%E) | EXPERIMENTAL | * Period 1: Regimen D (Organic phosphate (sodium glycerophosphate SGP)) * Period 2: Regimen C (Numeta G16%E) |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
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 as measured at screening. 4. Must be willing and able ...