TABLE 1.
Study day | Time (h) | na | Concn (μg/ml) (median [range]) | No. (%) of concn below lower limit of quantification |
---|---|---|---|---|
1 | Predose | 43 | 0 (0–0.627) | 42 (97.7) |
1 after dose | 16 | 0 (0–1.58) | 10 (62.5) | |
2–3 after dose | 41 | 1.13 (0–22.2) | 13 (31.7) | |
4–6 after dose | 13 | 3.69 (0–7.60) | 2 (15.4) | |
3 | Predose | 43 | 4.00 (0–41.6) | 2 (4.7) |
1 after dose | 18 | 3.65 (0–24.1) | 2 (11.1) | |
2–3 after dose | 43 | 2.54 (0–41.7) | 2 (4.7) | |
4–6 after dose | 15 | 3.17 (0–17.1) | 1 (6.7) | |
8 or 9 | Predose | 24 | 2.48 (0–30.5) | 1 (4.2) |
10 or 11 | Predose | 17 | 1.97 (0–28.1) | 2 (11.8) |
1 after dose | 12 | 2.39 (0–26.3) | 2 (16.7) | |
2–3 after dose | 13 | 2.14 (0–19.4) | 1 (7.7) | |
4–6 after dose | 10 | 2.16 (0.566–18.1) | 0 | |
12 or 13 | 12–72 after dose | 43 | 0 (0–11.9) | 25 (58.1) |
n, number of subject profiles that had adequate concentration data for evaluation. One patient had detectable LFF571 at baseline. The value was near the lower limit of quantification and was confirmed by repeat testing.