MAD Study Panel | Participants | Cmax | Tmax | AUC0–t | C24 | t1/2 | AI AUCτ |
---|---|---|---|---|---|---|---|
GM (CV%) | Median (Minimum–Maximum) | GM (CV%) | GM (CV%) | Mean (S.D.) | Mean(S.D.) | ||
n | ng/ml | h | ng⋅h/ml | ng/ml | |||
Panel 1 (50 mg) | |||||||
Day 1 | 6 | 134 (29) | 6 (5–12) | 1521 (25) | 47 (29) | ||
Day 14 | 5 | 323 (32) | 5 (4–5) | 4216 (57) | 204 (46) | 3.1 (1.2) | |
Day 28 | 5 | 293 (37) | 5 (2–8) | 4770 (49) | 165 (54) | 24 (10) | 3.3 (1.0) |
Panel 2 100mg | |||||||
Day 1 | 6 | 247 (28) | 6 (3–12) | 2912 (16) | 87 (36) | ||
Day 14 | 6 | 539 (18) | 8.5 (5–12) | 9085 (8) | 308 (12) | 3.1 (0.6) | |
Day 28 | 6 | 670 (20) | 5 (5–8) | 9080 (10) | 297 (16) | 29 (11) | 3.1 (0.7) |
Panel 3 (200 mg) | |||||||
Day 1 | 6 | 707 (19) | 5 (4–6) | 8023 (8.6) | 220 (5.6) | ||
Day 14 | 6 | 1975 (10) | 5 (4–8) | 31,376 (11) | 1151 (22) | 37 (7)a | 3.9 (0.4) |
AI, accumulation index; AUC0–t, area under the concentration-time curve from zero to the last quantifiable time; C24, concentrations at trough, 24 hours after previous dose.
↵a Predicted.