Journal
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
Volume 5, Issue 5, Pages 399-407Publisher
WILEY-BLACKWELL
DOI: 10.1002/cpdd.274
Keywords
batefenterol; GSK961081; bronchodilator; bifunctional molecule; fluticasone furoate
Categories
Funding
- GSK [201010]
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To investigate the pharmacokinetics of inhaled batefenterol (BAT) and fluticasone furoate (FF) given alone or in combination via ELLIPTA (R) dry powder inhaler (DPI-E), and BAT monotherapy via DISKUS (R) DPI (DPI-D). In this open-label, 6-way crossover study, 48 healthy subjects were randomized to 1 of 6 treatment sequences, comprising 6 single-dose treatment regimens: (1) BAT 1200 mu g via DPI-D; (2) BAT 1200 mu g via DPI-E without a lactose-filled second strip; (3) BAT 1200 mu g via DPI-E with a lactose-filled second strip; (4) BAT/FF 1200/300 mu g via DPI-E; (5) FF 300 mu g via DPI-E with a lactose-filled second strip; and (6) BAT/FF 900/ 300 mu g via DPI-E. Pharmacokinetic data were analyzed using noncompartmental methods. Plasma BAT area under the curve (AUC) and maximum plasma concentration (C-max) were similar for all treatments containing BAT 1200 mu g (geometric least-squares means [GLSM] ratio, 0.90-1.06). Plasma FF AUC and Cmax were reduced following BAT/FF 1200/ 300 mu g and 900/ 300 mu g versus FF 300 mu g monotherapy (GLSM ratio, 0.62-0.77). BAT 1200 mu g administered via DPI-E, alone or in combination with FF, resulted in similar systemic exposure versus BAT administered by DPI-D. FF exposure was reduced when administered in combination with BAT compared with FF alone.
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