Safety, tolerability, pharmacokinetics, pharmacodynamics, bioavailability and food effect of single doses of soticlestat in healthy subjects

por Wang, Shining, Chen, Grace, Merlo Pich, Emilio, Affinito, John, Cwik, Michael, Faessel, Hélène
Publicado 2021

Pharmacokinetics, pharmacodynamics and safety assessment of multiple doses of soticlestat in healthy volunteers

por Wang, Shining, Chen, Grace, Merlo Pich, Emilio, Affinito, John, Cwik, Michael, Faessel, Hélène M.
Publicado 2022

Population pharmacokinetics of pevonedistat alone or in combination with standard of care in patients with solid tumours or haematological malignancies

por Faessel, Hélène M., Mould, Diane R., Zhou, Xiaofei, Faller, Douglas V., Sedarati, Farhad, Venkatakrishnan, Karthik
Publicado 2019

A Phase I, Randomized, Double‐Blind, Placebo‐Controlled, Single‐Dose and Multiple‐Rising‐Dose Study of the BTK Inhibitor TAK‐020 in Healthy Subjects

por Esfandiari, Ehsanollah, Chen, Mary, Smithson, Glennda, Blair, Derek, Faessel, Helene, Wagner, John, Mclean, Lachy, Fedyk, Eric R.
Publicado 2021

Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia

por Mignot, Emmanuel, Bogan, Richard K, Emsellem, Helene, Foldvary-Schaefer, Nancy, Naylor, Melissa, Neuwirth, Rachel, Faessel, Hélène, Swick, Todd, Olsson, Tina
Publicado 2023

A phase I study of the investigational NEDD8-activating enzyme inhibitor pevonedistat (TAK-924/MLN4924) in patients with metastatic melanoma

por Bhatia, Shailender, Pavlick, Anna C., Boasberg, Peter, Thompson, John A., Mulligan, George, Pickard, Michael D., Faessel, Hélène, Dezube, Bruce J., Hamid, Omid
Publicado 2016

Effect of CYP3A inhibitors on the pharmacokinetics of pevonedistat in patients with advanced solid tumours

por Faessel, Hélène, Nemunaitis, John, Bauer, Todd M., Lockhart, A. Craig, Faller, Douglas V., Sedarati, Farhad, Zhou, Xiaofei, Venkatakrishnan, Karthik, Harvey, R. Donald
Publicado 2019

Phase I study assessing the mass balance, pharmacokinetics, and excretion of [(14)C]-pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors

por Zhou, Xiaofei, Sedarati, Farhad, Faller, Douglas V., Zhao, Dan, Faessel, Hélène M., Chowdhury, Swapan, Bolleddula, Jayaprakasam, Li, Yuexian, Venkatakrishnan, Karthik, Papai, Zsuzsanna
Publicado 2020

Orexin 2 receptor–selective agonist danavorexton improves narcolepsy phenotype in a mouse model and in human patients

por Evans, Rebecca, Kimura, Haruhide, Alexander, Robert, Davies, Ceri H., Faessel, Hélène, Hartman, Deborah S., Ishikawa, Takashi, Ratti, Emiliangelo, Shimizu, Kohei, Suzuki, Motohisa, Tanaka, Shinichiro, Yukitake, Hiroshi, Dauvilliers, Yves, Mignot, Emmanuel
Publicado 2022

Phase Ib study of pevonedistat, a NEDD8-activating enzyme inhibitor, in combination with docetaxel, carboplatin and paclitaxel, or gemcitabine, in patients with advanced solid tumo...

por Lockhart, A Craig, Bauer, Todd M., Aggarwal, Charu, Lee, Carrie B., Harvey, R Donald, Cohen, Roger B., Sedarati, Farhad, Nip, Tsz Keung, Faessel, Hélène, Dash, Ajeeta B., Dezube, Bruce J., Faller, Douglas V., Dowlati, Afshin
Publicado 2018

Pevonedistat in East Asian patients with acute myeloid leukemia or myelodysplastic syndromes: a phase 1/1b study to evaluate safety, pharmacokinetics and activity as a single agent...

por Handa, Hiroshi, Cheong, June-Won, Onishi, Yasushi, Iida, Hiroatsu, Kobayashi, Yukio, Kim, Hyeoung-Joon, Chiou, Tzeon-Jye, Izutsu, Koji, Tsukurov, Olga, Zhou, Xiaofei, Faessel, Helene, Yuan, Ying, Sedarati, Farhad, Faller, Douglas V., Kimura, Akiko, Wu, Shang-Ju
Publicado 2022