Table 1.
Overview of clinical studies used in popPK analysis
| Study no. (reference) | Study design | Study population | Doses | No. of subjects exposed | IV administration | Sampling time points |
|---|---|---|---|---|---|---|
| A [16] | Phase I, randomized, double-blind, placebo-controlled, single-centre, ascending dose | Healthy subjects | Part 1: | Part 1: | Pre-dose, 5, 10, 15, and 30 min, and 1, 4, 8, 24, 48, 72, and 168 h (n = 12) | |
| 1 mg/kg | 8 | 60 mg/min | ||||
| 2 mg/kg | 8 | Part 2: | ||||
| 4 mg/kg | 8 | 30 mg/20 s | ||||
| Part 2: | 30 mg/10 s | |||||
| 4 mg/kg | 11 | 30 mg/s | ||||
| B [12] | Phase I, randomized, double-blind, active- and placebo-controlled, parallel group, single-centre | Healthy subjects | 2 × 510 mg | 58 |
17 mL over 17 s |
Pre-dose, 5, 10, 15 and 30 min, 1, 4, 8, 12, 24, 24.08, 24.167, 24.25, 24.5, 25, 28, 32, 36, 48, 72, 96, 120, and 144 h after first dose (n = 23) |
| C [16] | Phase I, open-label, non-randomized, parallel group, ascending dose, single-centre | CKD stage 5D on HD | 1 × 125 mg | 10 | Over 5 min within 30 min after dialysis start | Pre-dose, 5, 10, 15, and 30 min, and 1, 2, 3, 48, and 96 h (n = 10) |
| 1 × 250 mg | 10 |
popPK population pharmacokinetics, IV intravenous, CKD chronic kidney disease, HD haemodialysis