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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00493220 | Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration | PHASE1 | COMPLETED | 30 | — | — | Jun 1, 2007 | Sep 1, 2007 | Dec 2, 2011 | - | — |
Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)
Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)
| Arm | Type | Description |
|---|---|---|
| HYLENEX SC, Placebo SC, IV | EXPERIMENTAL | subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention |
| HYLENEX SC, IV, Placebo SC | EXPERIMENTAL | subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention |
| Placebo SC, HYLENEX SC, IV | EXPERIMENTAL | subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention |
| Placebo SC, IV, HYLENEX SC | EXPERIMENTAL | subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention |
| IV, HYLENEX SC, Placebo SC | EXPERIMENTAL | IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention |
| IV, Placebo SC, HYLENEX SC | EXPERIMENTAL | IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention |
| Name | Type | Description |
|---|---|---|
| SC HYLENEX and Ceftriaxone | DRUG | single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes) |
| SC Placebo and Ceftriaxone | DRUG | single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes) |
| IV Ceftriaxone | DRUG | single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes) |
Inclusion Criteria: * Male or female, 18-65 years of age * If female: non-lactating; non-pregnant; and incapable of becoming pregnant, or taking specific precautions to avoid becoming pregnant before and during study * Normal clinical laboratory parameters * Adequate venous access in both upper ext...