3b.
Multiple Dose (Part 2): Pharmacokinetic Parameters for MC4-NN2-0453
| 0.75 mg/day | 1.5 mg/day | 3.0 mg/day | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Day 1 (n = 16) | Day 4 (n = 16) | Day 70 (n = 14) | Day 1 (n = 16) | Day 4 (n = 16) | Day 70 (n = 16) | Day 1 (n = 16) | Day 4 (n = 16) | Day 70 (n = 15) | |
| Cmax (ng/mL) | 49.7 (12.4) | 199 (41.7) | 723 (155) | 99.4 (21.9) | 387 (63.4) | NA | 229 (47.4) | 947 (184) | NA |
| tmax (hour) | 23.6 (1.5) | 19.9 (5.2) | 24.9 (15.4) | 23.9 (0.0) | 22.1 (3.6) | NA | 23.9 (0.0) | 21.3 (4.3) | NA |
| t½ (hour) | NA | NA | 232 (31.0) | NA | NA | 234 (40.4) | NA | NA | 253 (31.5) |
| AUC0–24h (h ng/mL) | 698a (168) | 4,320a (862) | 16,500a (3,580) | 1,140a (397) | 8,330a (1,420) | NA | 3,320a (954) | 20,800a (4,170) | NA |
Data are mean (standard deviation).
NA, not applicable.
Cohort 2 (1.5 mg/day) terminated around Visit 9 and were transferred to Visit 13 within 1 week.
Cohort 3 (3.0 mg/day) terminated around Visit 4 and were transferred to Visit 13 within 1 week.
a
Steady state has not been reached.