Table 3.
Pharmacokinetic results of JNJ-54175446 (Mean [SD]; tmax, median [range]) after administration of JNJ-54175446 at 600 mg on day 1, followed by 150 mg JNJ-54175446 qd on days 2 through 10 (group A) and after placebo on days 1 to 3, followed by 600 mg JNJ-54175446 on day 4, followed by 150 mg JNJ-54175446 qd on days 5 through 10 (group B).
| Day | Parameter | Group A | Group B |
|---|---|---|---|
| Day 1 | n | 26 | NP |
| Cmax (ng/mL) | 1181 (394) | NP | |
| Cmin (ng/mL) | BQL | NP | |
| Tmax (h) | 7.98 (3.93–23.33) | NP | |
| AUCt (ng.h/mL) | 21107 (6841) | NP | |
| Day 4 | n | 24a | 22b |
| Cmax (ng/mL) | 1630 (593) | 1225 (340) | |
| Cmin (ng/mL) | 1269 (433) | BQL | |
| Tmax (h) | 4.05 (0.00–23.33) | 6.09 (2.15–22.33) | |
| AUCt (ng.h/mL) | 34512 (10301) | 22383 (5909) | |
| Day 10 | n | 23c | 24d |
| Cmax (ng/mL) | 1932 (664) | 1894 (365) | |
| Cmin (ng/mL) | 1417 (510) | 1368 (297) | |
| Cavg (ng/mL) | 1671 (591) | 1615 (315) | |
| Tmax (h) | 4.00 (2.00–10.00) | 4.02 (3.73–10.00) | |
| AUCt (ng.h/mL) | 39905 (14069) | 38504 (7556) | |
| AUClast (ng.h/mL) | 158406 (74147) | 158953 (56655) | |
| AUC∞ (ng.h/mL) | 174933 (88211) | 167185 (55751) | |
| T1/2term (h) | 50.2 (17.8) | 55.5 (22.4) | |
| Peak/trough ratio | 1.27 (0.133) | 1.33 (0.171) |
BQL below quantification limit (<2.50 ng/mL), Cmax maximum plasma concentration, Cmin minimum observed plasma concentration, Cavg Average plasma concentration, AUCt area under the plasma concentration-time curve, AUClast area under the analyte concentration, AUC∞ area under the plasma concentration-time curve from time 0 to infinity, T1/2term terminal half-life.
an = 23 for AUCt.
bn = 24 for Cmin.
cn = 20 for AUC∞.
dn = 23 for AUClast and T1/2term; n = 22 for RA.AUC; n = 19 for AUC∞.