TABLE 3.
Summary of descriptive statistics of ABX464 PK parameters after the first and fourth single oral administration of 50 mg ABX464 (day 1 and day 10) under fasted and fed conditions to group 2 subjectsa
| Condition and/or value | Day 1 |
Day 10 |
||||||
|---|---|---|---|---|---|---|---|---|
| Cmax (ng/ml) | Tmaxb (h) | AUC0–t (ng · h/ml) | t1/2 (h) | Cmax (ng/ml) | Tmaxb (h) | AUC0–t (ng · h/ml) | t1/2 (h) | |
| Fasted | n = 12 | n = 12 | n = 12 | n = 4 | n = 12 | n = 12 | n = 12 | n = 9 |
| Mean | 11.19 | 1.75 | 31.49 | 1.11 | 10.75 | 1.8 | 28.26 | 1.15 |
| SD | 4.98 | 1.00–2.50 | 18.28 | 0.68 | 4.63 | 1.0–3.0 | 14.82 | 0.52 |
| GM | 10.00 | 26.92 | 0.99 | 9.93 | 25.16 | 1.08 | ||
| Fed | n = 12 | n = 12 | n = 12 | n = 6 | n = 12 | n = 12 | n = 12 | n = 8 |
| Mean | 46.67 | 2.50 | 112.66 | 0.77 | 55.38 | 2.3 | 111.24 | 0.74 |
| SD | 16.45 | 2.00–4.00 | 39.52 | 0.14 | 43.04 | 1.5–4.0 | 72.43 | 0.15 |
| GM | 42.92 | 105.22 | 0.76 | 42.79 | 93.19 | 0.73 | ||
| Point estimate | 4.29 | 3.91 | 4.31 | 3.70 | ||||
| 90% CI | 3.03–6.08 | 2.74–5.58 | 2.82–6.59 | 2.51–5.47 | ||||
Cmax, maximum concentration; Tmax, time to maximum concentration; AUC0–t, area under the concentration-time curve from time zero to the time of last quantifiable concentration; AUC0–∞, AUC from time zero to infinity; t1/2, apparent terminal elimination half-life; n, number of subjects; SD, standard deviation; GM, geometric mean; CI, confidence interval.
Instead of means and standard deviations, the values given for this parameter are medians and ranges (minimum–maximum), respectively.