Table 2.
Parameters (Unit) | Statistics/Category | Multiple Dose Study | ||||
---|---|---|---|---|---|---|
Placebo | Ferroquine | |||||
(N = 7) | 400 mg (N = 6) | 600 mg (N = 6) | 800 mg (N = 6) | 1000 mg (N = 1) | ||
Age (years) | Mean (SD) | 23.6 (5.3) | 30.2 (6.2) | 26.2 (6.3) | 24.5 (5.8) | NA |
Min - Max | 18 - 33 | 25 - 40 | 18 - 35 | 19 - 32 | ||
Height (cm) | Mean (SD) | 168.6 (6.5) | 167.5 (5.8) | 166.5 (10.5) | 170.8 (9.9) | NA |
Min - Max | 160 - 178 | 158 - 173 | 150 - 181 | 155 - 184 | ||
Weight (kg) | Mean (SD) | 63.0 (2.6) | 64.8 (8.3) | 59.8 (10.1) | 61.3 (5.0) | NA |
Min - Max | 59 - 66 | 55 - 75 | 50 - 74 | 56 - 70 | ||
BMI (kg/m2) | Mean (SD) | 22.24 (1.61) | 23.03 (1.74) | 21.48 (1.97) | 21.05 (1.19) | NA |
Min - Max | 20.5 - 25.0 | 21.3 - 25.3 | 19.2 - 24.5 | 19.8 - 23.3 | ||
BSA (m2) | Mean (SD) | 1.67 (0.09) | 1.73 (0.13) | 1.66 (0.19) | 1.72 (0.13) | NA |
Min - Max | 1.6 - 1.8 | 1.5 - 1.9 | 1.4 - 1.9 | 1.5 - 1.9 | ||
HR (bpm) | Mean (SD) | 53.8 (6.9) | 59.2 (7.8) | 55.6 (3.7) | 52.9 (1.2) | NA |
Min - Max | 48 - 63 | 52 - 72 | 51 - 60 | 48 - 62 | ||
QTc B (ms) | Mean (SD) | 366.6 (11) | 380.7 (15.7) | 359.0 (21.8) | 373.8 (24) | NA |
Min - Max | 358 - 384 | 367 - 409 | 150 - 181 | 340 - 406 | ||
QTc F (ms) | Mean (SD) | 373,9 (6.3) | 382.0 (11.7) | 362.8 (22.5) | 381.2 (24.5) | NA |
Min - Max | 368 - 382 | 372 - 403 | 335 - 404 | 340 - 399 |
NOTE: BMI: Body Mass Index; BSA: Body Surface Area; HR: Heart Rate; QTc (Bazett Fridericia); N: Count of patients; SD: standard deviation; Min: minimum; Max: maximum