Table 1.
Summary of pharmacokinetic parameters studied.
| Pharmacokinetic parameter | Daily maintenance dosage |
|
|---|---|---|
| Pegvaliase 20 mg | Pegvaliase 40 mg | |
| Median Tmax | 8 hours | |
| Cmax at steady state (mean ± SD) | 14.0 ± 16.3 mg/L | 16.7 ± 19.5 mg/L |
| Apparent volume of distribution (mean ± SD) | 26.4 ± 64.8 L | 22.2 ± 19.7 L |
| Apparent clearance at steady state (mean ± SD) | 0.39 ± 0.87 L/h | 1.25 ± 2.46 L/h |
| Half-life (mean ± SD) | 47 ± 42 hours | 60 ± 45 hours |
| Steady state plasma concentrations during maintenance treatment (mean ± SD) | 11.2 ± 9.0 mg/L | 10.4 ± 12.7 mg/L |
| Metabolism | Catabolic pathways, degraded into small peptides and amino acids | |
Abbreviations: Cmax, peak concentration; Tmax, time to peak concentration.