TABLE 2.
Demography and baseline characteristics.
| Variable | Categories | SAD | MAD | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Adult (Part A) | Elderly (Part A) | Food effect (Part B) | |||||||
| TRC150094 | Placebo | TRC150094 | Placebo | 100 mg | TRC150094 | TRC150094 | Placebo | ||
| 5–400 mg | (N = 6) | 50/150 mg | (N = 4) | (N = 6) | 50 mg | 150 mg | (N = 7) | ||
| (N = 18) | (N = 12) | (N = 12) | (N = 9) | ||||||
| Gender, n (%) | Female | 12 (66.7) | 4 (66.7) | 5 (41.7) | 2 (50.0) | 3 (50.0) | 3 (33.3) | 4 (44.4) | 2 (22.2) |
| Male | 6 (33.3) | 2 (33.3) | 7 (58.3) | 2 (50.0) | 3 (50.0) | 9 (47.4) | 5 (26.3) | 5 (26.3) | |
| Race, n (%) | Black/African | 1 (5.6) | 3 (50.0) | 0 | 0 | 1 (16.7) | 0 | 0 | 0 |
| Other (African/White) Mixed | 1 (5.6) | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | |
| Other: Metis | 0 | 0 | 1 (8.3) | 0 | 0 | 0 | 0 | 0 | |
| Other: West Indies | 1 (5.6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| White | 15 (83.3) | 3 (50.0) | 11 (91.7) | 4 (100.0) | 4 (66.7) | 0 | 0 | 0 | |
| Indian | 0 | 0 | 0 | 0 | 0 | 12 (100) | 9 (100) | 7 (100) | |
| Age (years) * | All Subjects | 46.1 (15.3) | 42.3 (19.1) | 70.4 (4.8) | 69.5 (0.5) | 50.0 (7.7) | 39.7 (11.8) | 46.0 (5.7) | 45.1 (10.5) |
| Height (cm) * | All Subjects | 167.9 (6.5) | 165.3 (6.2) | 164.8 (10.3) | 161.5 (7.1) | 165.7 (7.9) | 164.9 (7.8) | 161.2 (6.7) | 161.3 (7.8) |
| Weight (kg) * | All Subjects | 86.5 (15.0) | 79.0 (8.2) | 77.8 (12.0) | 72.5 (4.4) | 63.8 (10.0) | 84.3 (10.0) | 77.3 (6.7) | 82.6 (12.3) |
| BMI (kg/m 2 ) * | All Subjects | 30.6 (3.9) | 28.9 (2.6) | 28.5 (1.6) | 27.8 (0.8) | 23.2 (2.1) | 30.9 (2.4) | 29.8 (2.6) | 31.6 (2.4) |
| Smoking status, n (%) | Smoker | 2 (11.1) | 2 (33.3) | 2 (16.7) | 0 (0.0) | - | 0 (0.0) | 0 (0.0) | 1 (14.3) |
| Ex-smoker | 6 (33.3) | 2 (33.3) | 5 (41.7) | 1 (25.0) | - | 3 (25.0) | 1 (11.1) | 0 (0.0) | |
N = Number of subjects with non-missing values; n/% = Number/percentage of subjects with the given characteristics; * = Mean (SD).
Abbreviations: BMI, body mass index; SAD, single ascending dose; MAD, multiple ascending doses.