TABLE 6.
Day 1 pharmacokinetic parameters in the phase 1b MAD studya
| LHF-535 dose (mg/kg) | Statistic | Cmax (ng/mL) | Tmax (h) | AUC0–τ (h · ng/mL) | Cavg (ng/mL) |
|---|---|---|---|---|---|
| 450 mg | Mean | 1,765 | 3 | 14,165 | 590 |
| SD | 339 | 1 | 2,499 | 104 | |
| CV (%) | 19 | 31 | 18 | 18 | |
| Median | 1,728 | 4 | 14,629 | 610 | |
| 900 mg | Mean | 2,206 | 3 | 20,028 | 835 |
| SD | 520 | 1 | 3,176 | 132 | |
| CV (%) | 24 | 37 | 16 | 16 | |
| Median | 2,051 | 3 | 19,425 | 809 | |
| 1,125 mgb | Mean | 3,060 | 4 | 31,278 | 1,303 |
| SD | 951 | 1 | 10,126 | 422 | |
| CV (%) | 31 | 22 | 32 | 32 | |
| Median | 3,220 | 4 | 28,107 | 1,171 |
a
All treatment groups comprised 6 participants. Cavg, average concentration of drug in serum.
b
Participants in the 1,125-mg group received a loading dose of 2,250 mg once on day 1, followed by a maintenance dose of 1,125 mg/day on days 2 through 14.