Table 4.
Mean pharmacokinetic parameters of PRI‐002 in subjects (MAD study)
| PRI‐002 dose (mg) | Study day | Cmax (ng/mL) (CV %) | Tmax (hour) (CV %) | AUC0‐24 (ng*hour/m) (CV %) | AUC0‐tlast (ng*hour/m) (CV %) | AUC0‐inf (ng*hour/mL) (CV %) | t1/2α (hour) (CV %) | t1/2β (hour) (CV %) | Clast | Css trough |
|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 (160 mg) (n = 8) | Day 1 | 5.6 | 1.3 | 35.6 | ||||||
| (58%) | (50%) | (38%) | ||||||||
| Days 8‐12 | 1.28 | |||||||||
| (99%) | ||||||||||
| Day 14 | 7.2 | 1.3 | 62.7 | 147 | 181 | 4.6 | 38.5 | 0.6 | ||
| (53%) | (37%) | (64%) | (92%) | (64%) | (20%) | (34%) | (34%) | |||
| Cohort 2 (320 mg) (n = 6) | Day 1 | 13.8 | 1.3 | 76.2 | ||||||
| (76%) | (54%) | (75%) | ||||||||
| Days 20‐28 | 2.76 | |||||||||
| (57%) | ||||||||||
| Day 28 | 33.5 | 0.9 | 193 | 513 | 656 | 3.7 | 74.2 | 1.4 | ||
| (45%) | (64%) | (28%) | (40%) | (51%) | (25%) | (39%) | (47%) |
CV = coefficient of variation.