Table 3.
Summary of analyte concentrations for each dose in plasma samples.
| Analyte | M1, n | Dose (mg) | Samples at M1 above LLOQ, n (%)1 | Conc. (ng/mL) Median (IQR) |
M12, n | Samples at M12 above LLOQ, n (%)1 | Conc. (ng/mL) Median (IQR) |
M1 & M12 correlation |
|
|---|---|---|---|---|---|---|---|---|---|
| Pearson correlation | p-value | ||||||||
| ATV | 718 | 40 | 43 (97.7) | 4.86 (1.92-9.53) | 173 | – | – | – | – |
| 80 | 631 (93.6) | 5.67 (3.19-10.98) | 157 (90.7) | 4.97 (2.81-8.48) | 0.346 | 1.40 × 10−5 | |||
| 2-OH ATV | 40 | 42 (95.5) | 5.85 (2.80-8.81) | – | – | – | – | ||
| 80 | 640 (95.0) | 7.49 (4.26-12.76) | 163 (94.2) | 7.48 (3.86 – 11.42) | 0.294 | 1.76 × 10−4 | |||
| ATV L | 40 | 31 (70.5) | 3.98 (2.51-8.90) | – | – | – | – | ||
| 80 | 569 (84.4) | 4.94 (2.87-9.41) | 131 (75.7) | 4.33 (2.71-7.46) | 0.316 | 3.88 × 10−4 | |||
| 2-OH ATV L | 40 | 42 (95.5) | 4.64 (2.74-9.73) | – | – | – | – | ||
| 80 | 644 (95.5) | 7.49 (4.39-13.22) | 165 (95.4) | 6.63(4.07-9.86) | 0.268 | 5.94 × 10−4 | |||
| BSP | 736 | 1.25 | 140 (99.3) | 5.67 (4.31-7.63) | 182 | 26 (96.3) | 5.50 (4.28-7.05) | 0.640 | 4.37 × 10−22 |
| 2.5 | 316 (98.8) | 10.83 (8.24-14.05) | 83 (100.0) | 10.27 (6.78-13.67) | |||||
| 3.75 | 21 (100.0) | 17.50 (12.53-23.05) | 6 (100.0) | 13.34 (10.13-18.27) | |||||
| 5 | 167 (96.0) | 23.14 (17.08-28.86) | 49 (98.0) | 20.32 (15.50-30.68 | |||||
| 6.25 | 2 (100.0) | 55.342 | 1 (100.0) | 58.74 | |||||
| 7.5 | 24 (96.0) | 36.74 (27.35-45.67) | 4 (100.0) | 32.38 (12.70-51.56) | |||||
| 10 | 49 (98.0) | 43.93 (28.06-52.73) | 10 (90.9) | 53.37 (37.17 – 68.51) | |||||
| 20 | 3 (100.0) | 105.493 | 1 (100.0) | 167.24 | |||||
| CLP-CA | 811 | 75 | 792 (97.7) | 736.94 (392.13-1211.11) | 205 | 195 (95.12) | (737.58 (414.61-1124.49) | 0.255 | 3.34 × 10−4 |
Concentrations below the LLOQ were excluded from the median (IQR) concentration calculations and M1 to M12 correlation analysis. Pearson correlation analysis was performed on log10 transformed concentrations. 1 = the LLOQ was 0.5 ng/mL for ATV, 2-OH ATV, 2-OH ATV L and BSP, 1.2 ng/mL for ATV L, and 15 ng/mL for CLP-CA; 2 = n = 3 samples; 3 = n = 3 samples; 4 = n = 1 sample.