Publications by authors named "Helene Faessel"

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Orexin 2 receptor-selective agonist danavorexton (TAK-925) promotes wakefulness in non-human primates and healthy individuals.
Rebecca Evans, Haruhide Kimura, Masato Nakashima, Takashi Ishikawa, Hiroshi Yukitake, Hélène Faessel

J Sleep Res· October 2023

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Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia.
Emmanuel Mignot, Richard K Bogan, Helene Emsellem, Nancy Foldvary-Schaefer, Melissa Naylor, Hélène Faessel

Sleep· September 2023

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Safety and pharmacodynamics of a single infusion of danavorexton in adults with obstructive sleep apnea experiencing excessive daytime sleepiness despite adequate use of CPAP.
Richard K Bogan, James P Maynard, Rachel Neuwirth, Hélène Faessel, Todd Swick

Sleep Med· July 2023

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Orexin 2 receptor-selective agonist danavorexton improves narcolepsy phenotype in a mouse model and in human patients.
Rebecca Evans, Haruhide Kimura, Robert Alexander, Ceri H Davies, Hélène Faessel

Proc Natl Acad Sci U S A· August 2022

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Pharmacokinetics, pharmacodynamics and safety assessment of multiple doses of soticlestat in healthy volunteers.
Shining Wang, Grace Chen, Emilio Merlo Pich, John Affinito, Michael Cwik, Hélène M Faessel

Br J Clin Pharmacol· June 2022

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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 and in combination with azacitidine.
Hiroshi Handa, June-Won Cheong, Yasushi Onishi, Hiroatsu Iida, Yukio Kobayashi, Helene Faessel

J Hematol Oncol· May 2022

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Safety, tolerability, pharmacokinetics, pharmacodynamics, bioavailability and food effect of single doses of soticlestat in healthy subjects.
Shining Wang, Grace Chen, Emilio Merlo Pich, John Affinito, Michael Cwik, Hélène Faessel

Br J Clin Pharmacol· November 2021

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A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Dose and Multiple-Rising-Dose Study of the BTK Inhibitor TAK-020 in Healthy Subjects.
Ehsanollah Esfandiari, Mary Chen, Glennda Smithson, Derek Blair, Helene Faessel

Clin Transl Sci· May 2021

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Phase I study assessing the mass balance, pharmacokinetics, and excretion of [C]-pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors.
Xiaofei Zhou, Farhad Sedarati, Douglas V Faller, Dan Zhao, Hélène M Faessel

Invest New Drugs· April 2021

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The Oral Gonadotropin-releasing Hormone Receptor Antagonist Relugolix as Neoadjuvant/Adjuvant Androgen Deprivation Therapy to External Beam Radiotherapy in Patients with Localised Intermediate-risk Prostate Cancer: A Randomised, Open-label, Parallel-group Phase 2 Trial.
David P Dearnaley, Daniel R Saltzstein, John E Sylvester, Lawrence Karsh, Bryan A Mehlhaff, Hélène M Faessel

Eur Urol· August 2020

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Population pharmacokinetics of pevonedistat alone or in combination with standard of care in patients with solid tumours or haematological malignancies.
Hélène M Faessel, Diane R Mould, Xiaofei Zhou, Douglas V Faller, Farhad Sedarati

Br J Clin Pharmacol· November 2019

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Effect of CYP3A inhibitors on the pharmacokinetics of pevonedistat in patients with advanced solid tumours.
Hélène Faessel, John Nemunaitis, Todd M Bauer, A Craig Lockhart, Douglas V Faller

Br J Clin Pharmacol· July 2019

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Phase Ib study of pevonedistat, a NEDD8-activating enzyme inhibitor, in combination with docetaxel, carboplatin and paclitaxel, or gemcitabine, in patients with advanced solid tumors.
A Craig Lockhart, Todd M Bauer, Charu Aggarwal, Carrie B Lee, R Donald Harvey, Hélène Faessel

Invest New Drugs· February 2019

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Pevonedistat, a first-in-class NEDD8-activating enzyme inhibitor, combined with azacitidine in patients with AML.
Ronan T Swords, Steven Coutre, Michael B Maris, Joshua F Zeidner, James M Foran, Hélène M Faessel

Blood· March 2018

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A phase I study of the investigational NEDD8-activating enzyme inhibitor pevonedistat (TAK-924/MLN4924) in patients with metastatic melanoma.
Shailender Bhatia, Anna C Pavlick, Peter Boasberg, John A Thompson, George Mulligan, Hélène Faessel

Invest New Drugs· August 2016

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Phase I Study of the Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (TAK-924/MLN4924) in Patients with Advanced Solid Tumors.
John Sarantopoulos, Geoffrey I Shapiro, Roger B Cohen, Jeffrey W Clark, John S Kauh, Hélène M Faessel

Clin Cancer Res· February 2016

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Phase I Study of the Novel Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (MLN4924) in Patients with Relapsed/Refractory Multiple Myeloma or Lymphoma.
Jatin J Shah, Andrzej J Jakubowiak, Owen A O'Connor, Robert Z Orlowski, R Donald Harvey, Hélène M Faessel

Clin Cancer Res· January 2016

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Medical Castration Using the Investigational Oral GnRH Antagonist TAK-385 (Relugolix): Phase 1 Study in Healthy Males.
David B MacLean, Hongliang Shi, Hélène M Faessel, Fred Saad

J Clin Endocrinol Metab· December 2015

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Pevonedistat (MLN4924), a First-in-Class NEDD8-activating enzyme inhibitor, in patients with acute myeloid leukaemia and myelodysplastic syndromes: a phase 1 study.
Ronan T Swords, Harry P Erba, Daniel J DeAngelo, Dale L Bixby, Jessica K Altman, Hélène Faessel

Br J Haematol· May 2015

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Phase I dose-escalation trial of the oral investigational Hedgehog signaling pathway inhibitor TAK-441 in patients with advanced solid tumors.
Jonathan Goldman, S Gail Eckhardt, Mitesh J Borad, Kelly K Curtis, Manuel Hidalgo, Helene Faessel

Clin Cancer Res· March 2015

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Pharmacokinetic-pharmacodynamic modeling of the effect of varenicline on nicotine craving in adult smokers.
Patanjali Ravva, Marc R Gastonguay, Hélène M Faessel, Theodore C Lee, Raymond Niaura

Nicotine Tob Res· January 2015

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A review of the clinical pharmacokinetics and pharmacodynamics of varenicline for smoking cessation.
Hélène M Faessel, R Scott Obach, Hans Rollema, Patanjali Ravva, Kathryn E Williams

Clin Pharmacokinet· December 2010

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Population pharmacokinetic analysis of varenicline in adult smokers.
Patanjali Ravva, Marc R Gastonguay, Thomas G Tensfeldt, Hélène M Faessel

Br J Clin Pharmacol· November 2009

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Varenicline overdose in a teenager--a clinical pharmacology perspective.
Hans Rollema, Helene M Faessel, Kathryn E Williams

Clin Toxicol (Phila)· July 2009

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Pharmacokinetics, safety, and tolerability of varenicline in healthy adolescent smokers: a multicenter, randomized, double-blind, placebo-controlled, parallel-group study.
Helene Faessel, Patanjali Ravva, Kathryn Williams

Clin Ther· January 2009

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