Table 3.
Effects of Food, Sex, Age, and Race on PK of Apararenone After Single Oral Administration of Apararenone 20 mg (Studies 1 and 2)
| Study 1 | ||||||
|---|---|---|---|---|---|---|
| Parameter | (Control) Caucasian Male; Young: Aged ≤55 Years; Fasted (n = 6) | Fed (n = 5) | Female (n = 6) | Elderly: Aged ≥65 Years; (n = 6) | Black (n = 6) | Study 2 Japanese (n = 6) |
| Cmax, ng/mL | 239.7 (48.9) | 234.2 (32.3) | 261.8 (45.4) | 257.8 (68.0) | 239.8 (28.8) | 293.5 (30.1) |
| tmax, h a | 13.0 (2.0–71.9) | 6.0 (5.0–10.0) | 3.0 (1.5–24.0) | 3.5 (3.0–48.0) | 7.0 (2.0–10.1) | 7.0 (1.5–24.0) |
| AUC0–24, ng·h/mL | 4726 (813) | 4417 (1056) | 4629 (1080) | 4362 (888) | 4937 (692) | 5789 (713) |
| AUC0–t, ng·h/mL | 84,205 (13,582) b | 86,253 (20,084) | 99,169 (14,950) | 94,475 (17,211) | 88,701 (22,738) | 90,097 (26,315) |
| AUC0–∞, ng·h/mL | 90,816 (16,671) b | 90,886 (22,059) | 100,702 (14,729) | 96,294 (17,607) | 90,468 (22,849) | 92,489 (25,539) |
| t1/2, h | 304 (79) b | 266 (62) | 304 (72) | 344 (52) | 270 (93) | 225 (53) |
AUC0–24, area under the concentration‐time curve from time zero until 24 hours postdose; AUC0–t, area under the concentration‐time curve from time zero until the last quantifiable concentration; AUC0–∞, AUC from time zero extrapolated to infinity; Cmax, peak plasma concentration; SD, standard deviation; t1/2, elimination half‐life; tmax, time to Cmax.
Data shown are mean (standard deviation).
a
Median (range).
b
n = 4