Table 3.
Baseline demographics.
Cohort | Cohort 1 | Cohort 2 | Overall (n = 25) | ||||
---|---|---|---|---|---|---|---|
Sequence 1 (n = 6) | Sequence 2 (n = 7) | All (n = 13) | Sequence 1 (n = 6) | Sequence 2 (n = 6) | All (n = 12) | ||
Age, years | |||||||
Mean (s.d.) | 45.8 (9.2) | 57.3 (18.7) | 52 (15.7) | 58.2 (15.7) | 53.3 (7.5) | 55.8 (12.0) | 53.8 (13.9) |
Min-Max | 34–60 | 35–78 | 34–78 | 36–72 | 44–61 | 36–72 | 34–78 |
Height, m | |||||||
Mean (s.d.) | 1.81 (0.04) | 1.76 (0.05) | 1.79 (0.05) | 1.75 (0.04) | 1.77 (0.04) | 1.76 (0.04) | 1.77 (0.05) |
Min-Max | 1.75–1.88 | 1.68–1.81 | 1.68–1.88 | 1.72–1.82 | 1.70–1.82 | 1.70–1.82 | 1.68–1.88 |
Weight, kg | |||||||
Mean (s.d.) | 93.82 (18.73) | 87.19 (10.68) | 90.25 (14.66) | 96.00 (13.42) | 90.72 (9.57) | 93.36 (11.45) | 91.74 (13.04) |
Min-Max | 70.00–126.00 | 77.00–108.60 | 70.00–126.00 | 73.00–108.80 | 81.00–106.44 | 73.00–108.80 | 70.00–126.00 |
BMI, kg/m2 | |||||||
Mean (s.d.) | 28.36 (4.66) | 28.10 (3.54) | 28.22 (3.92) | 31.36 (3.84) | 28.82 (2.42) | 30.09 (3.33) | 29.11 (3.70) |
Min-Max | 21.85–35.65 | 23.50–33.15 | 21.85–35.65 | 24.39–34.74 | 25.51–32.49 | 24.39–34.74 | 21.85–35.65 |
Cohort 1, Sequence 1: 120 mg NT followed by a single dose of 80 mg TU; Cohort 1, Sequence 2: 80 mg TU followed by 120 mg NT; Cohort 2, Sequence 1: 200 mg NT in the fed state followed by 200 mg NT in the fasted state; Cohort 2, Sequence 2: 200 mg NT in the fasted state followed by 200 mg NT in the fed state.