Table 1. Baseline characteristics of the healthy male volunteers.
For the continuous variables we show the median (range). Of the 27 volunteers, 13 participated in both sub-studies.
| Part 1 - Ascending dose | Part 2 - Single 45 mg dose | Overall | |
|---|---|---|---|
| n | 24 | 16 | 27 |
| Age (years) | 32 (18–55) | 34 (20–58) | 32 (18–58) |
| Weight (kg) | 64 (46–86) | 64 (52–86) | 64 (46–86) |
| G6PD genotype | |||
| Viangchan (871G>A) | 12 | 6 | 12 |
| Mahidol (487G>A) | 4 | 2 | 4 |
| Canton (1376G>T) | 4 | 3 | 5 |
| Aures (143T>C) | 1 | 1 | 1 |
| Chinese-4 (392G>T)† | 1 | 0 | 1 |
| Orissa (131C>G) | 1 | 1 | 1 |
| Union (1360C>T) | 1 | 2 | 2 |
| Kaiping (1388G>A) | 0 | 1 | 1 |
| G6PD enzyme activity (U/g Hb) | 0.15 (0–1.9) | ||
| Haemoglobin (g/dL) | 14.3 (11.8–15.8) | 14.0 (12.3–15.9) | |
| Red cell count (×1012 per L) | 4.9 (4.2–6.0) | 5.1 (3.9–5.9) | |
| Reticulocyte count (%) | 2.4 (1.1–4.0) | 2.4 (1.0–2.9) | |
| Platelet count (×1000 per µL) | 285 (190–424) | 289 (174–412) | |
| Total white blood cell count (×1000 per µL) | 6.6 (4.8–9.3) | 6.6 (5.2–8.4) | |
| Methaemoglobin (%) | 0.5 (0–1.5) | 0.7 (0–1.4) | |
| AST (IU/L) | 23 (15–60) | 21 (14–36) | |
| ALT (IU/L) | 26 (10–85) | 22 (11–47) | |
| Creatinine (mg/dL) | 0.9 (0.8–1.1) | 1.0 (0.7–1.1) | |
| Total bilirubin (mg/dL) | 0.6 (0.3–1.6) | 0.7 (0.3–1.3) | |
| Haptoglobin (g/L) | 1.1 (0.5–1.7) | 1.1 (0.5–1.7) | |
| CYP2D6 genotypes | |||
| *10/*10 | 6 | 4 | 8 |
| *2/*10 | 7 | 4 | 7 |
| *1/*10 | 6 | 4 | 7 |
| *1/*2 | 3 | 3 | 3 |
| *1/*1 | 2 | 1 | 2 |
| Haemoglobin E trait‡ | 7 | 4 | 7 |
| Presumptive alpha-thalassaemia trait* | 5 | 5 | 7 |
*
See definition in Methods.
†
Also known as Quing Yan (Minucci et al., 2012).
‡
Haemoglobin typing done by electrophoresis in Part 1 only.