Table 5.
Sigmoid Emax model parameter estimates for urine cGMP/Cr (initial 6 months of the phase II study)
| Pharmacokinetic parameter |
E0 (pmol/mg Cr) MPE (95% CI) |
Emax (pmol/mg Cr) MPE (95% CI) |
EC50 MPE (95% CI) |
h MPE (95% CI) |
|---|---|---|---|---|
| Cmax | 579 (− 331 to 1490) | 10,100 (7720–12,600) | 4790 pg/mL (3270–6320) | 2.04 (0.811–3.26) |
| AUC0-t | 393 (− 503 to 1290) | 11,800 (8140–15,400) | 2.22 × 105 pg-min/mL (7.48 × 104 to 3.69 × 105) | 1.12 (0.486–1.76) |
Cmax maximum observed plasma concentration, AUC0-t area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, CI confidence interval, E0 baseline level, EC50 pharmacokinetic parameter value producing half maximal effect on cGMP/Cr, Emax maximum possible effect, cGMP cyclic guanosine monophosphate, cGMP/Cr cGMP normalized to creatinine, h Hill coefficient, MPE model parameter estimates