Table 2.
CHF6001 derived pharmacokinetic parameters following single doses (PK population)
| CHF6001 dose | Pharmacokinetic parameter
|
|||
|---|---|---|---|---|
| Cmax, pg/mL | tmax, h | AUC0–t, pg.h/mL | t½, h | |
|
| ||||
| SDDPI | ||||
| 20 µg (N=8) | 18.9 (22.2) | 0.08 (0.08, 2) | 31.6 (91.3) | 5.6 (9.3)a |
| 100 µg (N=8) | 63.8 (32.8) | 1.74 (1.0, 2) | 1,477 (33.8) | 28.2 (0.0)b |
| 200 µg (N=8) | 140.2 (28.0) | 1.03 (0.5, 2) | 2,782 (18.9) | 30.1 (29.7)c |
| 400 µg (N=7) | 194.7 (25.4) | 2.0 (2, 6) | 5,384 (24.9) | 45.3 (40.8)a |
| 800 µg (N=7) | 432.4 (24.3) | 2.0 (1.0, 4) | 10,600 (28.7) | 26.3 (1.0)a |
| 1,600 µg (N=7) | 730.0 (29.5) | 2.0 (0.5, 2) | 17,990 (32.6) | 27.4 (NC)d |
| 2,000 µg (N=5) | 982.6 (11.6) | 2.0 (1.5, 2) | 25,550 (25.3) | 37.3 (15.5)a |
| MDDPI | ||||
| 2,400 µg (N=9) | 1,234 (19.6) | 3.0 (2, 4) | 35,178 (23.4) | 49.1 (40.1)e |
| 4,000 µg (N=8) | 2,551 (19.2)f | 3.0 (2, 4)f | 75,754 (24.9)f | 44.0 (17.7)e |
| 4,800 µg (N=8) | 2,723 (22.3) | 3.0 (1.5, 6) | 77,409 (25.6) | 40.0 (35.6)f |
Notes: Data are geometric mean (% coefficient of variation), except tmax which is median (range). PK population is defined as all subjects in the safety population who had at least one valid PK measurement and who had no major PK-related protocol deviations.
n=3;
n=2;
n=5;
n=1;
n=4;
n=7.
Abbreviations: AUC0–t, area under the curve from administration to last measurable concentration; Cmax, maximum plasma concentration; PK, pharmacokinetics; MDDPI, study medication administered via multi-dose dry-powder inhaler; NC, not calculated (geometric mean from only one subject); SDDPI, study medication administered via single-dose dry-powder inhaler; t½, terminal elimination half life; tmax, time to maximum concentration.