TABLE 1.
Demographics
| Part 1 (n = 70) | Part 2 (n = 16) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 14) | BAY 2433334 Oral Solution, mg | BAY 2433334 IR Tablet, mg | BAY 2433334 5 × 5 mg IR Tablet | |||||||
| 5 (n = 8) | 12.5 (n = 8) | 25 (n = 8) | 25 (n = 8) | 50 (n = 8) | 100 (n = 8) | 150 (n = 8) | Fasted–fed (n = 8) | Fed–fasted (n = 8) | ||
| Age, years | ||||||||||
| Mean (SD) | 29.0 (8.1) | 34.4 (7.9) | 25.0 (4.4) | 30.0 (5.0) | 25.1 (5.1) | 27.9 (4.8) | 29.6 (5.5) | 30.1 (5.8) | 32.1 (7.9) | 30.3 (8.5) |
| Range | 19–4 | 24–45 | 19–30 | 22–39 | 20–33 | 21–33 | 21–38 | 22–39 | 24–44 | 20–43 |
| Weight, kg | ||||||||||
| Mean (SD) | 77.1 (11.8) | 81.8 (13.1) | 80.0 (9.9) | 85.1 (9.4) | 80.5 (7.2) | 83.6 (10.1) | 84.2 (19.2) | 77.3 (10.1) | 79.5 (10.9) | 83.8 (15.0) |
| Range | 62.0–102.4 | 58.0–102.0 | 69.0–93.0 | 74.6–104.7 | 73.0–92.3 | 70.8–97.3 | 62.3–125.1 | 66.2–99.0 | 59.9–96.9 | 69.0–115.8 |
| BMI, kg/m2 | ||||||||||
| Mean (SD) | 24.2 (2.8) | 24.8 (3.8) | 23.6 (2.6) | 26.1 (2.7) | 24.2 (2.5) | 26.2 (1.6) | 25.2 (3.3) | 24.3 (3.0) | 24.3 (3.2) | 25.5 (3.0) |
| Range | 19.2–28.7 | 18.9–29.5 | 20.4–28.4 | 21.6–29.9 | 21.1–27.6 | 23.9–28.2 | 20.6–29.2 | 19.6–29.9 | 19.8–29.3 | 21.0–29.5 |
| Smoking status, n (%) | ||||||||||
| Never | 9 (64.3) | 5 (62.5) | 5 (62.5) | 5 (62.5) | 3 (37.5) | 6 (75.0) | 5 (62.5) | 6 (75.0) | 6 (75.0) | 4 (50.0) |
| Former | 1 (7.1) | 0 | 2 (25.0) | 2 (25.0) | 3 (37.5) | 0 | 2 (25.0) | 0 | 1 (12.5) | 1 (12.5) |
| Current | 4 (28.6) | 3 (37.5) | 1 (12.5) | 1 (12.5) | 2 (25.0) | 2 (25.0) | 1 (12.5) | 2 (25.0) | 1 (12.5) | 3 (37.5) |
Abbreviations: BMI, body mass index; IR, immediate‐release; SD, standard deviation.