Table 2.
Demographic and baseline characteristics
| Dose escalation/expansion (n = 252) | Mass balance and biotransformation (n = 6) | Hepatic impairment | CYP3A4 drug–drug interaction | Food effects | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild (n = 8) | Moderate (n = 8) | Normal (n = 8) | GIL (n = 21) | ITCZ + GIL (n = 20) | FLCZ + GIL (n = 20) | RIF + GIL (n = 20) | Fed (n = 16) | Fasted (n = 16) | |||
| Sex | |||||||||||
| Male | 129 (51) | 3 (50) | 5 (63) | 5 (63) | 5 (63) | 19 (91) | 20 (100) | 19 (95) | 18 (90) | 14 (88) | 14 (88) |
| Female | 123 (49) | 3 (50) | 3 (37) | 3 (37) | 3 (37) | 2 (9) | 0 | 1 (5) | 2 (10) | 2 (12) | 2 (12) |
| Race | |||||||||||
| White | 213 (85) | 6 (100) | 7 (88) | 8 (100) | 8 (100) | 12 (57) | 9 (45) | 13 (65) | 12 (60) | 6 (38) | 9 (56) |
| Other | 39 (15) | 0 | 1 (12) | 0 | 0 | 9 (43) | 11 (55) | 7 (35) | 8 (40) | 10 (62) | 7 (44) |
| Age, yearsa | 62 (21–90) | 59 (49–75) | 58.5 (55–65) | 53.5 (48–65) | 54 (48–58) | 33 (22–53) | 32 (22–55) | 40.5 (20–54) | 31.5 (22–49) | 39 (26–54) | 38 (29–51) |
| Weight, kgb | 75.3 (18.1) | 88.2 (34.0) | 73.9 (14.6) | 76.5 (15.1) | 74.4 (17.5) | 80.2 (12.2) | 80.7 (11.0) | 79.6 (10.5) | 76.4 (9.5) | 78.1 (8.7) | 81.6 (11.6) |
| BMI, kg/m2b | 26.1 (5.6) | 32.8 (9.7) | 27.0 (5.6) | 28.0 (4.5) | 27.2 (4.2) | 25.97 (3.02) | 25. 6 (2.6) | 25.7 (2.8) | 25.2 (1.9) | 25.9 (2.5) | 26.5 (2.8) |
AME absorption, metabolism, and excretion, BMI body mass index, CYP cytochrome P450, DDI drug–drug interaction, FLCZ fluconazole, GIL gilteritinib, ITCZ itraconazole, RIF rifampicin
Data presented as n (%) unless otherwise indicated
aData presented as median (range)
bData presented as mean (standard deviation)