Table 2.
Subject demographics for the three arms of the trial
| Group/CBD dose | Sex [n (%)] | Race [n (%)] | Age, years [mean (SD)] | BMI, kg/m2 [mean (SD)] | |||
|---|---|---|---|---|---|---|---|
| Male | Female | White | White/Asian | White/Black/African American | |||
| Single ascending dose arm | |||||||
| Placebo (n = 8) | 3 (37.5) | 5 (62.5) | 7 (87.5) | 0 | 1 (12.5) | 23.1 (1.4) | 23.65 (2.31) |
| 1500 mg (n = 6) | 1 (16.7) | 5 (83.3) | 6 (100.0) | 0 | 0 | 26.0 (3.2) | 23.73 (2.45) |
| 3000 mg (n = 6) | 3 (50.0) | 3 (50.0) | 6 (100.0) | 0 | 0 | 25.0 (4.7) | 23.15 (2.33) |
| 4500 mg (n = 6) | 0 | 6 (100.0) | 6 (100.0) | 0 | 0 | 25.8 (7.9) | 21.38 (1.71) |
| 6000 mg (n = 6) | 2 (33.3) | 4 (66.7) | 4 (66.7) | 1 (16.7) | 1 (16.7) | 22.8 (3.2) | 23.60 (2.53) |
| Multiple dose arm | |||||||
| Placebo (n = 6) | 1 (16.7) | 5 (83.3) | 4 (66.7) | 1 (16.7) | 1 (16.7) | 23.3 (1.9) | 22.48 (2.31) |
| 750 mg (n = 9) | 2 (22.2) | 7 (77.8) | 9 (100.0) | 0 | 0 | 28.6 (8.5) | 22.28 (3.03) |
| 1500 mg (n = 9) | 5 (55.6) | 4 (44.4) | 8 (88.9) | 0 | 1 (11.1) | 25.1 (4.8) | 22.23 (2.33) |
| Food effect arma | |||||||
| 750 mg (n = 12) | 4 (33.3) | 8 (66.7) | 12 (100) | 0 | 0 | 25.1 (6.2) | 23.34 (1.90) |
BMI body mass index, CBD cannabidiol, n number of subjects, SD standard deviation
aSubjects in the food effect arm had previously completed the single ascending dose arm of the trial in either the 1500, 3000 or 4500 mg dose groups