TABLE 4.
GFH312 PK parameters postdose on day 1 and day 14 in part II.
| GFH312 | GFH312 | GFH312 | |
|---|---|---|---|
| 60 mg q.d. (N = 6) | 120 mg q.d. (N = 7) | 200 mg q.d. (N = 6) | |
| Day 1, geomean (geoCV%) | |||
| C max (ng/mL) | 587.7 (61.0) | 587.8 (63.1) | 946.1 (47.9) |
| T max (h) a | 4.0 (4.0–4.1) | 4.0 (2.0–23.7) | 4.1 (2.0–8.3) |
| AUC0–t (h ng/mL) | 7770.9 (50.4) | 8473.9 (40.9) | 13,031.9 (35.1) |
| Day 14, geomean (geoCV%) | |||
| C max,ss (ng/mL) | 738.0 (22.5) b | 921.7 (28.3) c | 1290.2 (29.0) e |
| C min,ss (ng/mL) | 249.3 (51.3) b | 362.8 (32.6) c | 543.6 (33.5) e |
| T max,ss (h) a | 4.0 (1.0–4.1) b | 2.0 (2.0–3.9) c | 4.0 (2.0–4.0) e |
| AUC0–tau (h ng/mL) | 10,656.5 (34.4) b | 12,973.5 (24.1) c | 18,963.7 (30.6) e |
| RAAUC | 1.3 (39.3) b | 1.3 (55.2) d | 1.6 (35.2) f |
| RACmax | 1.1 (47.4) b | 1.5 (62.4) c | 1.2 (45.8) e |
Abbreviations: AUC0–t , area under the drug concentration‐time curve from time zero to the last quantifiable concentration; AUC0–tau, area under the drug concentration‐time curve from time zero to end of dosing period; AUC0–24, area under the drug concentration‐time curve from time zero to 24 h; C max, maximum concentration; C max,ss, maximum concentration at steady‐state; C min,ss, minimum concentration at steady‐state; geoCV%, geometric coefficient of variation; geomean, geometric mean; PK, pharmacokinetic; QD, once daily; RAAUC, accumulation ratio calculated by AUC; RACmax, accumulation ratio calculated by C max; T max, time to maximum concentration; T max,ss, time to maximum concentration at steady‐state.
T max and T max,ss are reported as median (range).
n = 5, one subject discontinued treatment on day 7 due to adverse event.
n = 6, one subject discontinued treatment on day 12 due to personal reasons.
n = 5, one subject discontinued treatment on day 12 due to personal reasons, and for another subject, AUC0–24 on day 1 and RAAUC could not be calculated.
n = 5, one subject discontinued treatment on day 8 due to an adverse event.
n = 3, for three subjects, AUC0–24 on day 1 and RAAUC could not be calculated.