Table I.
Summary of Demographic and Clinical Data for Studies ZP-005 and ZP-006
| STUDY | |||
|---|---|---|---|
| ZP-005 | ZP-006 | ZP-005/006 | |
| Age, years | 46 (35–61) | 55 (42–66) | 52.5 (35–66) |
| Median (range) | |||
| Weight, kg | 77.3 (54.1–94.1) | 70.6 (52.3–102.3) | 71.65 (52.3–102.3) |
| Median (range) | |||
| Height, cm | 163 (158–172.7) | 162.6 (149–176.4) | 162.6 (149–176.4) |
| Median (range) | |||
| BMI, kg/m2 | 28 (21–36) | 27 (20–34) | 27 (20–36) |
| Median (range) | |||
| Baseline ALT, U/L | 35 (17–85) | 20 (7–46) | 23.5 (7–85) |
| Median (range) | |||
| Baseline AST, U/L | 40 (25–99) | 21 (16–32) | 24.5 (16–99) |
| Median (range) | |||
| Baseline CrCl, mL/min | 121.2 (78.7–176.9) | 73.1 (30–105) | 91.45 (30–176.9) |
| Median (range) | |||
| Healthy (n) | 4 | 9 | 13 |
| Moderate hepatic impairment (Child–Pugh class B) | 7 | – | 7 |
| Mild renal impairment (CrCl = 50–80 mL/min) | – | 6 | 6 |
| Moderate renal impairment (CrCl = 30–50 mL/min) | – | 6 | 6 |
BMI body mass index, ALT alanine aminotransferase, AST aspartate aminotransferase, CrCl creatinine clearance