Table 1.
Demographic and clinical characteristics of participants at baseline in the single dose study
| Parameters (Unit) | Statistics/Category | Single Dose Study | |||||
|---|---|---|---|---|---|---|---|
| Placebo | Ferroquine | ||||||
| (N = 10) | 400 mg (N = 6) | 800 mg (N = 6) | 1200 mg (N = 6) | 1400 mg (N = 6) | 1600 mg (N = 6) | ||
| Age (years) | Mean (SD) | 30.5 (9.4) | 32.0 (4.4) | 31.2 (6.1) | 30.5 (8.8) | 24.3 (6.3) | 26.5 (4.0) |
| Min - Max | 18 - 44 | 27 - 37 | 22 - 38 | 20 - 42 | 18 - 34 | 19 - 30 | |
| Height (cm) | Mean (SD) | 167.3 (8.7) | 168.8 (7.0) | 168.7 (3.9) | 166.2 (7.4) | 172.7 (6.7) | 164.3 (5.0) |
| Min - Max | 147 - 176 | 160-176 | 163-174 | 154-174 | 163 - 183 | 157 - 172 | |
| Weight (kg) | Mean (SD) | 66.0 (7.8) | 62.8 (9.3) | 64.7 (3.6) | 62.7 (8.5) | 65.2 (3.5) | 60.6 (5.2) |
| Min - Max | 55 - 78 | 50-71 | 58-59 | 52-75 | 61 - 70 | 57 - 71 | |
| BMI (kg/m2) | Mean (SD) | 23.59 (2.40) | 21.92 (1.85) | 22.77 (1.61) | 22.65 (1.83) | 21.92 (1.25) | 22.48 (0.88) |
| Min - Max | 20.1-27.6 | 19.5-24.3 | 19.8-24.5 | 19.6-24.8 | 19.7 - 23.0 | 21.9 - 24.0 | |
| BSA (m2) | Mean (SD) | 1.74 (0.14) | 1.72 (0.16) | 1.74 (0.05) | 1.70 (0.15) | 1.74 (0.14) | 1.78 (0.08) |
| Min - Max | 1.5 - 1.9 | 1.5 - 1.8 | 1.7 - 1.8 | 1.5 - 1.9 | 1.5 - 1.9 | 1.7 - 1.9 | |
| HR (bpm) | Mean (SD) | 50.9 (6.9) | 56.3 (3.7) | 54.4 (5.9) | 53.3 (9.3) | 56.8 (6.6) | 54.6 (9.3) |
| Min - Max | 42 - 67 | 51 - 61 | 46 - 63 | 41 - 62 | 47 - 66 | 44 - 66 | |
| QTc B (ms) | Mean (SD) | 374.7 (19.6) | 378.9 (20.6) | 374.0 (11) | 368.3 (16.9) | 369.4 (28.9) | 371.3 (20.6) |
| Min - Max | 347 - 405 | 346 - 405 | 362 - 392 | 337 - 388 | 327 - 408 | 334 - 396 | |
| QTc F (ms) | Mean (SD) | 386.5 (22.1) | 384.0 (19.3) | 380.5 (9.3) | 376.9 (13.5) | 373.4 (26.7) | 378.4 (20.8) |
| Min - Max | 357 - 416 | 350 - 403 | 363 - 389 | 356 - 391 | 341 - 416 | 353 - 409 | |
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