Table 5.
Pharmacokinetic parameters of difelikefalin and metabolites in plasma (pooled samples by time point)
| Healthy subjects | |||||
|---|---|---|---|---|---|
| Parameter | Difelikefalin | MP1 | MP2 | MP3 | MP4 |
| tmax (h) | 0.083 | 0.083 | 0.083 | 0.083 | 0.083 |
| Cmax (ng-eq/mL) | 23.8 | 0.356 | 0.170 | 0.280 | 0.140 |
| AUClast (h*ng-eq/mL) | 30.3 | 0.145 | |||
| AUClast (% total) | 99.52 | 0.48 | |||
| Subjects on hemodialysis | |||||
|---|---|---|---|---|---|
| Parameter | Difelikefalin | MP1 | MP2 | MP3 | MP4 |
| tmax (h) | 0.083 | 0.083 | 0.083 | ||
| Cmax (ng-eq/mL) | 24.7 | 0.548 | 0.340 | ||
| AUClast (h*ng-eq/mL) | 283 | 0.271 | 0.0634 | ||
| AUClast (% total) | 99.88 | 0.10 | 0.02 | ||
AUClast area under the curve from time 0 h to last quantifiable concentration, Cmax maximum concentration, tmax time to reach Cmax