Table 4.
Pharmacokinetic parameters for CEP-8983 by smoking status/receiving medications that affect gastric pH (day 5 of cycle 1)
| Pharmacokinetic parameters, mean ± SD | Nonsmoker without medication affecting gastric pH n = 13 | Smoker and/or with medication affecting gastric pH n = 11 |
|---|---|---|
| C max (ng/mL) | 607.5 ± 319.87 | 352.5 ± 380.57 |
| AUC0–∞ (ng h/mL) | 4,111.0 ± 4,126.79 | 2,838.9 ± 5,740.57 |
| AUC0–t (ng h/mL) | 3,138.0 ± 2,160.74 | 1,339.3 ± 2,127.07 |
| AUCτ (ng h/mL) | 3,851.1 ± 3,578.78 | 2,304.7 ± 4,161.29 |
| t max (h) | 0.6 ± 0.66 | 0.6 ± 0.66 |
| t 1/2 (h) | 1.0 ± 0.59 | 0.7 ± 0.77 |
| CL/F (L/h) | 20.4 ± 25.80 | 67.1 ± 62.14 |
| V/F(L) | 58.1 ± 60.23 | 102.3 ± 100.76 |
| Percentage extrapolation (%) | 3.7 ± 3.82 | 5.5 ± 8.29 |
| λ z (1/h) | 0.1 ± 0.13 | 0.2 ± 0.21 |
AUC 0–∞ area under the plasma drug concentration–time curve from time 0 to infinity, AUC 0–t area under the plasma drug concentration–time curve from time 0 to the time of the last measurable drug concentration, AUC τ area under the plasma drug concentration–time curve for 1 dosing interval, CL/F total body clearance from plasma after oral administration, C max maximum observed plasma concentration, λ z terminal plasma elimination rate-constant, t 1/2 half-life, t max time to maximum observed plasma concentration, V/F apparent volume of distribution after oral administration