Table 6.
Parameter estimates of the final intravenous pharmacokinetic model of inebilizumab in adult subjects
| Parameter | Estimate | RSE (%) | Bootstrap 95% range |
IIV (CV%) | RSE (%) | Bootstrap 95% range |
|---|---|---|---|---|---|---|
| CL (mL/day) | 188 | 2.2 | 175–199 | 27 | 25 | 23–30 |
| Weight on CLa | 0.57 | 15.8 | 0.38–0.78 | |||
| Vc (mL) | 2950 | 1.4 | 2860–3030 | 17 | 30 | 11–21 |
| Weight on Vca | 0.39 | 22.4 | 0.21–0.55 | |||
| Q (mL/day) | 363 | 6.0 | 326–408 | |||
| Weight on Qa | 0.84 | 21.1 | 0.34–1.28 | |||
| Vp (mL) | 2570 | 2.8 | 2420–2720 | 16 | 45 | 10–21 |
| Weight on Vpa | 0.40 | 27.9 | 0.20–0.61 | |||
| Vmax (µg/day) | 832 | 5.3 | 539–1400 | 30 | 61 | 0.3–40 |
| Study CP200 on Vmax (%) | 210 | 19.5 | 116–328 | |||
| Kdec (/day) | 0.00294 | 55.1 | 0.0000294–0.00498 | |||
| Km (µg/mL) | 5.89 | 25.5 | 3.51–11.1 | |||
| Residual variability | ||||||
| Proportional error (%CV) | 21.8 | 4.6 | 19.6–23.7 |
CL clearance, CV coefficient of variation, IIV interindividual variability, Kdec first-order rate constant for decrease in Vmax, Km concentration corresponding to half of Vmax, NA not applicable, Q inter‑compartmental clearance RSE relative standard error, Vc volume of distribution in the central compartment, Vmax maximum velocity of the saturable clearance process, Vp volume of distribution in the peripheral compartment
aNatural exponent