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- W1937647632 abstract "RATIONALE To evaluate the safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile of RV568 in GOLD stage II/III Chronic Obstructive Pulmonary Disease (COPD) patients. METHODS 30 COPD patients aged 40–75 years were recruited. Inhaled RV568 50mg, 100mg or placebo were given daily for 14 days. Forced expiratory volume in 1 second (FEV1) was recorded primarily for safety; PK was measured on Days (D) 1, 7 and 14. PD included 54 sputum and 20 serum biomarkers measured by Luminex, biochemical assay or ELISA. RESULTS Twenty eight subjects completed the study, 2 met the withdrawal criterion of decrease in FEV1 >20%. One subject [placebo] had a serious adverse event (hospitalised for COPD exacerbation) otherwise no clinically significant safety signals attributable to RV568 were reported. On D14 compared to baseline, RV568 showed a significant (p PK data showed plasma exposure was approximately 2 fold greater on D14 than D1, the effective half-life was 19-29 h and steady state was reached by D7. RV568 showed a significant (p In serum RV568 showed a significant (p CONCLUSIONS The safety, PK and PD profile support progression of inhaled RV568 into further clinical studies in COPD." @default.
- W1937647632 created "2016-06-24" @default.
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- W1937647632 date "2013-09-01" @default.
- W1937647632 modified "2023-09-26" @default.
- W1937647632 title "Safety, pharmacokinetic and pharmacodynamic profile of RV568, a narrow spectrum kinase inhibitor, following repeat inhaled dosing in COPD patients" @default.
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