TABLE 1.
| Study 1 (IV infusion/oral switch) | Study 2 (multiple doses of IV infusion) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| PBO (N = 3) |
FMGX 1,000 mg and 600 mg IV; 800 mg oral (N = 9) |
PBO | FMGX | ||||||||
| PBO 1 (N = 8) |
PBO 2 (N = 2) |
PBO 3 (N = 2) |
Cohort A 1,500/900 mg (N = 9) |
Cohort B 900/900 mg (N = 6) |
Cohort C 1,000/900 mg (N = 6) |
Cohort D 1,000/750 mg (N = 6) |
Cohort E 1,000/850 mg (N = 6) |
Cohort F 1,000/900 mg (N = 6) |
|||
| Sex (male, %) | 67 | 100 | 25 | 0 | 0 | 22.2 | 0 | 16.7 | 33.3 | 50.0 | 16.7 |
| Race (White/Black/Asian/Other, %) | 67/0/33/0 | 78/11/0/11 | 87.5/0/12.5/0 | 100/0/0/0 | 100/0/0/0 | 66.7/0/0/33.3 | 100/0/0/0 | 83.3/0/0/16.7 | 100/0/0/0 | 83.3/0/16.7/0 | 83.3/16.7/0/0 |
| Age, mean (SD) (years) | 52 (11) | 42 (18) | 25 (4) | 28 (3) | 38 (15) | 29 (13) | 30 (11) | 26 (6) | 23 (2) | 29 (3) | 34 (11) |
| Weight, mean (SD) (kg) | 74.8 (27.5) | 79.4 (9.3) | 64.7 (9.9) | 65.8 (0.3) | 67.1 (4.0) | 68.7 (8.2) | 74.8 (6.2) | 67.7 (10.5) | 70.6 (7.9) | 71.6 (5.1) | 73.2 (10.4) |
| Height, mean (SD) (cm) | 170 (21) | 179 (8) | 167 (9) | 174 (1) | 174 (3) | 169 (8) | 174 (6) | 173 (5) | 174 (8) | 172 (5) | 172 (8) |
| BMI, mean (SD) (kg/m2) | 25.4 (4.1) | 24.9 (3.9) | 23.1 (1.7) | 21.9 (0.3) | 22.2 (2.1) | 24.0 (2.5) | 24.7 (1.6) | 22.5 (2.5) | 23.3 (1.5) | 24.2 (1.4) | 24.7 (1.8) |
Cohorts: PBO 1, PBO BID on day 1 and QD on days 2 to 7 IV infusion; PBO 2, PBO BID on days 1 and 2 and QD on days 3 to 7 IV infusion; PBO 3, PBO BID on day 1 and QD on days 2 to 7 IV infusion with ondansetron; A, 1,500 mg BID on day 1 and 900 mg QD on days 2 to 7 FMGX IV infusion; B, 900 mg BID on days 1 and 2 and 900 mg QD on days 3 to 7 FMGX IV infusion; C, 1,000 mg BID on day 1 and 900 mg QD on days 2 to 7 FMGX IV infusion with ondansetron; D, 1,000 mg BID on day 1 and 750 mg QD on days 2 to 7 FMGX IV infusion; E, 1,000 mg BID on day 1 and 850 mg QD on days 2 to 7 FMGX IV infusion; F, 1,000 mg BID on day 1 and 900 mg QD on days 2 to 7 FMGX IV infusion.
BID, twice daily; BMI, body mass index; FMGX, fosmanogepix; IV, intravenous; PBO, placebo; QD, once daily; SD, standard deviation.