Safety, pharmacokinetics and dose-response characteristics of GSK2269557, an inhaled PI3Kδ inhibitor under development for the treatment of COPD

Autor: Cahn, A., Hamblin, J.N., Begg, M., Wilson, R., Dunsire, L., Sriskantharajah, S., Montembault, M., Leemereise, C.N., Galinanes-Garcia, L., Watz, H., Kirsten, A.M., Fuhr, R., Hessel, E.M.

Publikováno v: In Pulmonary Pharmacology & Therapeutics October 2017 46:69-77

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A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Repeat Doses of Inhaled Nemiralisib in Adults with Persistent, Uncontrolled Asthma.

Autor: Khindri S; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Cahn A; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Begg M; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Montembault M; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Leemereise C; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Cui Y; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Hogg A; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Wajdner H; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Yang S; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Robertson J; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Hamblin JN; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Ludwig-Sengpiel A; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Kornmann O; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.)., Hessel EM; Respiratory Therapy Area Unit (S.K.), Clinical Pharmacology Science and Study Operations (M.M.), Global Clinical Safety and Pharmacovigilance (Y.C.), and Clinical Pharmacology Modelling and Simulation, Quantitative Sciences, RD Projects Clinical Platforms and Sciences (S.Y.), GSK, Stockley Park, Uxbridge, Middlesex, United Kingdom; Discovery Medicine (A.C.), Refractory Respiratory Inflammation Discovery Performance Unit (M.B., H.W., J.N.H., E.M.H.), Clinical Pharmacology Science and Study Operations (A.H.), and Clinical Statistics (J.R.), GSK, Stevenage, Hertfordshire, United Kingdom; Clinical Operations Department, GSK, Zeist, The Netherlands (C.L.); KLB Gesundheitsforschung Lübeck, Lübeck, Germany (A.L.-S.); and IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany (O.K.) edith.m.hessel@gsk.com.

Publikováno v: The Journal of pharmacology and experimental therapeutics [J Pharmacol Exp Ther] 2018 Dec; Vol. 367 (3), pp. 405-413. Date of Electronic Publication: 2018 Sep 14.

PI3Kγδ inhibition suppresses key disease features in a rat model of asthma.

Autor: Pinkerton, James W.^1,2 (AUTHOR), Preite, Silvia¹ (AUTHOR), Piras, Antonio¹ (AUTHOR), Zervas, Dimitrios^1,2 (AUTHOR), Markou, Thomais^1,2 (AUTHOR), Freeman, Mark S.^1,2 (AUTHOR), Hofving, Tobias¹ (AUTHOR), Ivarsson, Emil¹ (AUTHOR), Bonvini, Sara J.^1,2 (AUTHOR), Brailsford, Wayne¹ (AUTHOR), Yrlid, Linda¹ (AUTHOR), Belvisi, Maria G.^1,2 (AUTHOR), Birrell, Mark A.^1,2 (AUTHOR) mark.birrell@astrazeneca.com

Publikováno v: Respiratory Research. 4/23/2024, Vol. 25 Issue 1, p1-10. 10p.

A Novel Combined Dry Powder Inhaler Comprising Nanosized Ketoprofen-Embedded Mannitol-Coated Microparticles for Pulmonary Inflammations: Development, In Vitro–In Silico Characterization, and Cell Line Evaluation.

Autor: Banat, Heba¹ (AUTHOR) banat.habosh@gmail.com, Csóka, Ildikó¹ (AUTHOR) csoka.ildiko@szte.hu, Paróczai, Dóra² (AUTHOR) paroczai.dora@med.u-szeged.hu, Burian, Katalin² (AUTHOR) burian.katalin@med.u-szeged.hu, Farkas, Árpád³ (AUTHOR) farkas.arpad@ek-cer.hu, Ambrus, Rita¹ (AUTHOR) ambrus.rita@szte.hu

Publikováno v: Pharmaceuticals (14248247). Jan2024, Vol. 17 Issue 1, p75. 26p.