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Table 1 Hormones of the HPA axis: mean difference from baseline

From: Safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of BI 187004, an inhibitor of 11beta-hydroxysteroid dehydrogenase-1, in healthy male volunteers with overweight or obesity

Parameter [Reference Range]/Time point/Difference from baseline Placebo
N = 17
2.5 mg
N = 6
5 mg
N = 6
10 mg
N = 6
20 mg
N = 6
40 mg
N = 6
80 mg
N = 6
160 mg
N = 6
240 mg
N = 6
360 mg
N = 6
Cortisol [171 – 536 nmol/L]
 Baseline 396.1 359.7 338.1 395.6 330.8 301.3 325.7 258.1 219.4 347.8
 24:00 -39.0 -77.1 1.8 -78.7 18.4 -48.8 102.6 -49.2 -7.3 -40.0
 96:00 -46.6 -65.3 -75.0 -128.8 -34.1 -75.5 -64.4 -69.9 -5.1 -132.9
ACTH [1.03 – 10.74 pmol/L]
 Baseline 4.96 3.80 4.26 4.59 3.25 2.52 2.01 2.82 3.64 3.42
 24:00 -1.22 0.59 0.53 0.78 1.53 1.44 4.69 1.34 0.87 1.30
 96:00 -1.84 -0.46 -1.65 -1.35 -0.58 -0.01 1.36 0.05 -0.27 0.38
DHEA-s [2.6 – 13.0 μmol/L]
 Baseline 6.4 5.2 5.0 5.1 5.8 5.7 6.0 4.1 5.2 4.3
 24:00 0.0 0.7 1.6 1.2 2.2 1.7 2.6 1.6 1.6 1.2
 96:00 1.1 2.1 0.9 1.9 2.1 2.3 2.4 2.2 2.3 1.6
Androstenedione [1.1 – 10.9 nmol/L]
 Baseline 9.6 11.0 10.5 8.1 5.9 8.4 9.8 6.2 7.5 6.7
 24:00 -2.3 0.2 1.2 1.3 3.7 3.7 8.1 2.6 5.0 3.2
 96:00 -2.6 -1.8 -3.7 -3.4 3.8 0.1 0.5 1.5 2.7 -0.3
Total Testosterone [9.9 – 27.9 nmol/L]
 Baseline 16.1 18.4 16.7 18.7 15.4 20.3 16.3 13.4 15.6 11.6
 24:00 0.2 0.1 -0.9 -0.2 -1.3 -0.5 0.8 1.0 -2.8 -0.3
 96:00 -0.3 -0.3 -0.7 -2.0 -1.0 -0.8 0.6 2.4 -2.4 0.7
SHBG [10 – 80 nmol/L]
 Baseline 25.7 32.1 28.2 33.7 28.4 37.6 29.1 29.5 27.2 28.5
 24:00 1.8 2.6 3.0 3.4 2.9 0.6 2.1 1.9 2.3 0.9
 96:00 0.6 -0.1 2.7 0.2 1.3 -1.8 -1.3 -0.8 2.5 -2.2