Table 1.
Demographic and baseline characteristics for safety and pharmacokinetic populations
| Characteristic | Safety populationa (N = 23) |
Pharmacokinetic populationb (N = 24) |
|---|---|---|
| Age (year) | ||
| Mean (SD) | 53.3 (10.98) | 52.4 (11.67) |
| Min, max | 26, 65 | 26, 65 |
| Sex [n (%)] | ||
| Male | 14 (60.9%) | 15 (62.5%) |
| Femalec | 9 (39.1%) | 9 (37.5%) |
| Race [n (%)] | ||
| Asian | 1 (4.3%) | 1 (4.2%) |
| Black or African American | 17 (73.9%) | 18 (75.0%) |
| White | 5 (21.7%) | 5 (20.8%) |
| Ethnicity [n (%)] | ||
| Not Hispanic or Latino | 20 (87.0%) | 21 (87.5%) |
| Hispanic or Latino | 3 (13.0%) | 3 (12.5%) |
| Height (cm) | ||
| Mean (SD) | 171.33 (8.861) | 171.33 (8.861)d |
| Min, Max | 155.0, 188.0 | 155.0, 188.0d |
| Weight (kg) | ||
| Mean (SD) | 83.78 (15.746) | 83.78 (15.746)d |
| Min, max | 47.1, 111.5 | 47.1, 111.5d |
| BMI (kg/m2) | ||
| Mean (SD) | 28.49 (4.650) | 28.49 (4.650)d |
| Min, max | 19.6, 34.8 | 19.6, 34.8d |
Min, minimum; Max, maximum; BMI, body mass index
aAll subjects who received at least 1 RBP-7000 injection
bAll subjects who received oral risperidone or at least 1 dose of RBP-7000 and provided an adequate number of blood samples for determination of pharmacokinetic parameters
cOne female in each population was of childbearing potential
dn = 23