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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