Open-label, single-dose, parallel group study investigating the effect of extremes of body weight on PK, PD, safety, and
tolerability of a single 10 mg oral dose of apixaban in healthy volunteers aged 18 to 45 years
tolerability of a single 10 mg oral dose of apixaban in healthy volunteers aged 18 to 45 years
Study population
| Characteristic | Low (≤ 50 kg) (n=18) | Reference (65-85 kg) (n=18) | High (≥ 120 kg) (n=19) |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 23 (4) | 28 (7) | 29 (8) |
| Range | 18-31 | 18-43 | 19-41 |
| Gender, n (%) | |||
| Male | 2 (11) | 8 (44) | 16 (84) |
| Female | 16 (89) | 10 (56) | 3 (16) |
| Race, n (%) | |||
| White | 11 (61) | 15 (83) | 17 (89) |
| Black | 1 (6) | 0 | 0 |
| Asian | 4 (22) | 2 (11) | 0 |
| Other* | 2 (11) | 1 (6) | 2 (11) |
| Weight (kg) | |||
| Mean (SD) | 47 (3.6) | 75 (5.5) | 137 (18.3) |
| Range | 38-50 | 67-84 | 120-175 |
| Body mass index (kg/m2) | |||
| Mean (SD) | 18.8 (2) | 26.3 (2) | 42.6 (6) |
| Range | 17-22 | 22-30 | 32-54 |
