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Table 4 Steady-State Plasma PK Parameters for navafenterol on Day 16 (PK Population)

From: Navafenterol (AZD8871) in healthy volunteers: safety, tolerability and pharmacokinetics of multiple ascending doses of this novel inhaled, long-acting, dual-pharmacology bronchodilator, in two phase I, randomised, single-blind, placebo-controlled studies

 

Study A

Study Ba

Navafenterol

300 μg

Navafenterol

600 μg

Navafenterol

900 μg

Navafenterol

300 μg

Navafenterol

600 μg

Navafenterol

900 μg

AUC0–24, pg.h/mL

 n

6

5

6

6

6

6

 Geometric mean

2103

5508

7077

1633

5596

8332

 %GCV

25.20

47.25

19.87

42.47

23.31

16.78

AUClast, pg.h/mL

 n

6

6

6

6

6

6

 Geometric mean

4432

10,380

12,570

7167

19,340

30,470

 %GCV

26.17

52.30

21.75

30.23

19.05

22.20

Cmax, pg/mL

 n

6

6

6

6

6

6

 Geometric mean

406.5

1018

1830

297.2

1220

1559

 %GCV

34.44

53.64

28.47

69.43

35.03

28.02

tmax, h

 n

6

6

6

6

6

6

 Median

1.50

1.50

1.50

1.04

1.49

1.50

 Min–max

1.50–1.53

1.48–1.50

1.50–1.50

0.75–1.50

0.98–2.00

1.00–1.98

t½λz, h

 n

6

5

5

6

6

6

 Arithmetic mean

78.51

62.39

70.19

209.2

236.0

250.7a

 SD

11.01

16.69

4.144

40.76

34.54

67.04

Rac (Cmax)

 n

6

5

6

6

6

6

 Arithmetic mean

1.032

1.054

1.181

0.9047

2.372

1.362

 Min–max

0.881–1.23

0.979–1.12

0.843–1.40

0.391–1.30

1.26–5.10

1.16–1.55

Rac (AUC0–24)

 n

6

5

6

6

6

6

 Arithmetic mean

1.675

1.451

1.463

1.393

3.062

1.879

 Min–max

1.33–2.14

1.25–1.60

1.20–1.58

0.891–1.88

1.71–6.87

1.54–2.09

  1. aNote that a longer sampling scheme was used in study B (samples collected up to 336 h following the last dose) compared with study A (samples collected up to 96 h following the last dose)
  2. AUC area under the curve, AUC0–24 AUC from 0 to 24 h, AUClast AUC from time 0 to time of the last quantifiable measurable concentration, Cmax maximum plasma concentration, %GCV geometric coefficient of variation, max maximum, min minimum, n number of non-missing observations, PK pharmacokinetic, Rac (Cmax) accumulation ratio for Cmax, Rac (AUC0–24) accumulation ratio for AUC0–24, SD standard deviation, t½λz terminal half-life, tmax time to reach Cmax
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Respiratory Research

ISSN: 1465-993X

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