Table 2.
% ≥ LOQ | Meana [ng/mL] | Median [ng/mL] | Maximum [ng/mL] |
|||||
---|---|---|---|---|---|---|---|---|
All | Female | Male | All | Female | Male | |||
OTA | ||||||||
2019 Phase Ib | 98.7 | 0.42 | 0.33 | 0.50 | 0.27 | 0.26 | 0.30 | 23.0 |
2019 Phase IIc | 99.2 | 0.38 | 0.36 | 0.40 | 0.28 | 0.27 | 0.31 | 1.73 |
2005 | 99.2 | 0.40 | 0.32 | 0.47 | 0.28 | 0.28 | 0.28 | 14.6 |
1995d | 100 | 0.39 | 0.27 | 0.49 | n.d. | 0.24 | 0.30 | 6.02 |
2′R-OTA | ||||||||
2019 Phase I | 48.1 | 0.23 | 0.24 | 0.22 | n.d. | n.d. | n.d. | 1.31 |
2019 Phase II | 52.1 | 0.24 | 0.24 | 0.23 | 0.10 | 0.11 | 0.10 | 1.15 |
2005 | 50.7 | 0.20 | 0.20 | 0.20 | 0.10 | 0.10 | 0.10 | 0.98 |
aMean is calculated in positive samples, excluding values < LOD
b1 extreme value of approx. 700 ng/mL was excluded
cPhase II samples: 240 samples taken 2–9 months later from Phase I donors
ddata from Zimmerli and Dick (1995)
n.d. not determined