Pharmacokinetics and ADME Characterization of Intravenous and Oral [14C]-Linerixibat in Healthy Male Volunteers

Autor: Zamek-Gliszczynski, Maciej J., Kenworthy, David, Bershas, David A., Sanghvi, Mitesh, Pereira, Adrian I., Mudunuru, Jennypher, Crossman, Lee, Pirhalla, Jill L., Thorpe, Karl M., Dennison, Jeremy M.T.J., McLaughlin, Megan M., Allinder, Matthew, Swift, Brandon, O’Connor-Semmes, Robin L., Young, Graeme C.

Publikováno v: Drug Metabolism and Disposition; 2021, Vol. 49 Issue: 12 p1109-1117, 9p

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Pharmacokinetics and ADME Characterization of Intravenous and Oral [ ¹⁴ C]-Linerixibat in Healthy Male Volunteers.

Autor: Zamek-Gliszczynski MJ; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.) maciej.x.zamek-gliszczynski@gsk.com., Kenworthy D; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Bershas DA; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Sanghvi M; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Pereira AI; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Mudunuru J; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Crossman L; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Pirhalla JL; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Thorpe KM; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Dennison JMTJ; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., McLaughlin MM; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Allinder M; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Swift B; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., O'Connor-Semmes RL; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.)., Young GC; Drug Metabolism and Disposition (M.J.Z.-G., D.A.B., J.M., J.L.P.), Medicine Development (M.M.M.), and Development Biostatistics (M.A.), GlaxoSmithKline, Collegeville, Pennsylvania; Drug Metabolism and Disposition (D.K., G.C.Y.), and Bioanalysis, Immunogenicity and Biomarkers (A.I.P.), GlaxoSmithKline, Ware, United Kingdom; Pharmaron ABS Inc., Germantown, Maryland (M.S.); Covance, Harrogate, United Kingdom (L.C.); Global Clinical Development, GlaxoSmithKline, Brentford, United Kingdom (K.M.T.); Hammersmith Medicines Research, London, United Kingdom (J.M.T.J.D.); Clinical Pharmacology, Modeling and Simulation, GlaxoSmithKline, RTP, North Carolina (B.S.); and Clinical Pharmacology, Modeling and Simulation, Parexel, Durham, North Carolina (R.L.O.-S.).

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2021 Dec; Vol. 49 (12), pp. 1109-1117. Date of Electronic Publication: 2021 Oct 08.