Table 6.
Noncompartmental pharmacokinetic parameters of BI 655066 in cynomolgus monkey. Pharmacokinetic parameters for BI 655066 in cynomolgus monkeys after a single 1 mg/kg intravenous or subcutaneous dose. Serum concentrations were measured using an IL23-capture ELISA. Pharmacokinetic parameters were determined by noncompartmental analysis. Data represent the mean ± SD of three monkeys per dose route. AUCinf: area under the serum concentration-time curve from zero to infinity; CL: serum clearance; Vss: steady-state distribution volume; t1/2 half-life; Cmax: maximum observed serum concentration; Tmax: the time Cmax was observed; F%: bioavailability
| Dose (mg/kg) | Route | Animal/ group | AUCinf (ug·day/mL) | Clearance (mL/day/kg) | Vss (mL/kg) | t1/2 (day) | Cmax (ug/mL) | Tmax (day) | F% |
|---|---|---|---|---|---|---|---|---|---|
| 1.0 | i.v. | Mean | 202 | 5.18 | 88.3 | 12.2 | ND | ND | |
| SD | 33.5 | 0.8 | 3.12 | 2.28 | ND | ND | |||
| 1.0 | s.c. | Mean | 142 | ND | ND | 9.15 | 10.1 | 2.11 | 70.4 |
| SD | 33.3 | ND | ND | 1.87 | 3.14 | 1.84 | 16.5 |
ND = not determined.