Physiologically‐Based Pharmacokinetic Model‐Informed Drug Development for Fenebrutinib: Understanding Complex Drug‐Drug Interactions

Autor: Yuan Chen, Fang Ma, Nicholas S. Jones, Kenta Yoshida, Po‐Chang Chiang, Matthew R. Durk, Matthew R. Wright, Jin Yan Jin, Leslie W. Chinn

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology, Vol 9, Iss 6, Pp 332-341 (2020)

Fenebrutinib is a CYP3A substrate and time‐dependent inhibitor, as well as a BCRP and OATP1B transporter inhibitor in vitro. Physiologically‐based pharmacokinetic (PBPK) modeling strategies with the ultimate goal of understanding complex drug‐d

Externí odkaz: https://doaj.org/article/4b03517de89446c89515dc196f2449a5

Efficacy, Safety, and Pharmacodynamic Effects of the Bruton’s Tyrosine Kinase Inhibitor Fenebrutinib (GDC‐0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double‐Blind, Placebo‐Controlled Trial

Autor: Rupal Desai, Pedro C. Miranda, Anna Maura Fernandes, Viviane A de Souza, Nicholas S. Jones, Juan J Jaller-Raad, Rodrigo Garcia Salinas, Pascal Guibord, Balazs Toth, Jason A. Hackney, Chin Lee, Katie Tuckwell, Leslie W. Chinn, Richard Furie, Armend Lokku, Nandhini Ramamoorthi, Julie Rae, David A. Isenberg, Michael J. Townsend, Olivia Hwang, A. Mcgregor, Joshua Galanter, Alyssa Morimoto

Publikováno v: Arthritis & Rheumatology. 73:1835-1846

Objective Fenebrutinib (GDC-0853) is a noncovalent, oral, and highly selective inhibitor of Bruton's tyrosine kinase (BTK). The efficacy, safety, and pharmacodynamics of fenebrutinib in systemic lupus erythematosus (SLE) were assessed in this phase I

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::562983679bc61e79458393e85a7692f8
https://doi.org/10.1002/art.41811

Understanding the Effect of Hydroxypropyl‐β‐Cyclodextrin on Fenebrutinib Absorption in an Itraconazole–Fenebrutinib Drug–Drug Interaction Study

Autor: Jacob Z. Chen, Susan Wong, Karthik Nagapudi, Po-Chang Chiang, Leslie W. Chinn, Chen Mao, Yuan Chen, Emile Plise, Nicholas S. Jones, Matthew R. Durk, Jia Liu

Publikováno v: Clinical Pharmacology and Therapeutics

Cyclodextrins are widely used pharmaceutical excipients, particularly for insoluble compounds dosed orally, such as the oral solution of itraconazole, which is frequently used in clinical drug-drug interaction studies to inhibit cytochrome P450 3A. S

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3df4ef202208088f2f19224579f02d17
https://doi.org/10.1002/cpt.1943

Fenebrutinib versus Placebo or Adalimumab in Rheumatoid Arthritis: A Randomized, Double-Blind, Phase II Trial (ANDES Study)

Autor: Stanley Cohen, Katie Tuckwell, Tamiko R. Katsumoto, Rui Zhao, Joshua Galanter, Chin Lee, Julie Rae, Balazs Toth, Nandhini Ramamoorthi, Jason A. Hackney, Alberto Berman, Nemanja Damjanov, Dmytro Fedkov, Slawomir Jeka, Leslie W. Chinn, Michael J. Townsend, Alyssa M. Morimoto, Mark C. Genovese, Alejandro Porto, Amelia Granel, Cecilia Asnal, Eduardo Fabian Mysler, Gladys Alicia Testa, Jose Luis Velasco Zamora, Jose Luis Cristian Moreno, Juan Pablo Gulin, Julio Hofman, Maria Rosa Ulla, Mirtha Sabelli, Pablo Alejandro Mannucci, Pablo Jorge Maid, Ana Cláudia Cauceglia Melazzi, Antônio Scafuto Scotton, Antônio Carlos Ximenes, Elisete Funes, Emerson Alves Gimenez, Flora Maria D’Andrea Marcolino, João Francisco Marques Neto, Mauro Waldemar Keiserman, Sebastião Cézar Radominski, Sônia Maria Alvarenga Anti Loduca Lima, Thaís Rohde Pavan, Valderílio Feijó Azevedo, Aneliya Koleva, Antoaneta Toncheva, Daniela Bichovska, Delina Ivanova, Dimitar Penev, Emil Dimitrov, Mariyana Mihaylova, Nadezhda Kapandjieva, Natalia Marinova, Tanya Aleksieva, Tanya Tsvetanova, Tsvetanka Petranova, Valentina Popova, Yuliy Spasov, Carlos Enrique Toro, Carlos Ernesto Arteaga Unigarro, Edwin Jauregui, Javier Dario Marquez Hernandez, Juan Jose Jaller Raad, Patricia Julieta Velez Sanchez, Chang Keun Lee, Chang‐Hee Suh, Eun Young Lee, Sang‐Heon Lee, Seong Wook Kang, Shin‐Seok Lee, Yun Jong Lee, Beatriz Elena Zazueta Montiel, Blanca Irma Pinzon de la O, Daniel Xibille Friedmann, Francisco Rosas Lopez, Isaura Rodriguez Torres, Luis Jara Quezada, Marco Maradiaga Ceceña, Miguel Cortes Hernandez, Miguel Saavedra Salinas, Agnieszka Rapa, Agnieszka Pawtel, Agnieszka Zielinska, Anna Dudek, Anna Rychlewska‐Hanczewska, Anna Strzelecka, Artur Racewicz, Barbara Stasiuk, Katarzyna Gruszecka, Krystyna Dworak, Tomasz Lowenhoff, Alexey Maslyanskiy, Andrey Rebrov, Diana Krechikova, Elena Zhugrova, Evgeniya Shmidt, Galina Matsievskaya, Irina Vinogradova, Irina Ler, Larisa Eliseeva, Ludmila Savina, Marina Stanislav, Mikhail Sandin, Natalia Zyablova, Nikolay Korshunov, Nino Mosesova, Oksana Polovnikova, Olga Nesmeyanova, Ruzana Samigullina, Sergey Moiseev, Sergey Noskov, Tatiana Raskina, Tatiana Popova, Valeriy Marchenko, Aleksandar Jovanovski, Bojana Stamenkovic, Gorica Ristic, Milijanka Lazarevic, Mirjana Veselinovic, Nada Vujasinovic‐Stupar, Predrag Ostojic, Andriy Yagensky, Andriy Gnylorybov, Dmytro Rekalov, Dmytroo Reshotko, Georgiy Dzyak, Iurii Gasanov, Ludmila Khimion, Mykola Stanislavchuk, Natalya Prykhodko, Oleg Nadashkevych, Oleg Bortkevych, Orest Abrahamovych, Roman Yatsyshyn, Samvel Turyanytsya, Svitlana Smiyan, Vadym Vizir, Victoria Kachur, Vira Tseluyko, Vladyslav Povoroznyuk, Volodymyr Koshlia, Vyacheslav Zhdan, Yurii Lymar, Yuriy Mostovoy, Angela Hawkes, Arthur Mabaquiao, Cong‐Qiu Chu, Craig Scoville, David Wyatt, Debra Weinstein, Harris McIlwain, Jacqueline Vo, Jeffrey Poiley, Joseph Forstot, Kathryn Dao, Mark Turner, Mark Genovese, Michael Borofsky, Paul Caldron, Philip Waller, Robert Levin, Samy Metyas, Scott Stein, Sharukh Shroff, Shirley Pang, Tauseef Syed, Vishala Chindalore

Publikováno v: Arthritis & Rheumatology (Hoboken, N.j.)

Objective To evaluate fenebrutinib, an oral and highly selective noncovalent inhibitor of Bruton's tyrosine kinase (BTK), in patients with active rheumatoid arthritis (RA). Methods Patients with RA and an inadequate response to methotrexate (MTX) (co

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b5fa5a95d88cab7e31679b10f2b1f1ab
https://pubmed.ncbi.nlm.nih.gov/32270926

Physiologically-Based Pharmacokinetic Model-Informed Drug Development for Fenebrutinib: Understanding Complex Drug-Drug Interactions

Autor: Leslie W. Chinn, Matthew Wright, Kenta Yoshida, Po-Chang Chiang, Nicholas S. Jones, Jin Yan Jin, Fang Ma, Matthew R. Durk, Yuan Chen

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology
CPT: Pharmacometrics & Systems Pharmacology, Vol 9, Iss 6, Pp 332-341 (2020)

Fenebrutinib is a CYP3A substrate and time-dependent inhibitor, as well as a BCRP and OATP1B transporter inhibitor in vitro. Physiologically-based pharmacokinetic (PBPK) modeling strategies with the ultimate goal of understanding complex drug-drug in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::933ca5c8abf3eae329830ed83a53859c
https://pubmed.ncbi.nlm.nih.gov/32383787