Zobrazeno 1 - 10
of 52
pro vyhledávání: '"James Keirns"'
Autor:
Jean-Philippe Couderc, Nenad Sarapa, Charles Benson, Corina Dota, Randy Brown, Mark Ticktin, Jim Ferry, Wojciech Zareba, Venkat Jarugula, Borje Darpo, Catherine Ortemann-Renon, Steve Riley, Thuan G. Pham, Georg Ferber, James Keirns
Publikováno v:
The Journal of Clinical Pharmacology. 60:125-139
The JTpeak interval has been proposed as a new biomarker to demonstrate mixed ion channel effects, potentially leading to reduced late-stage electrocardiogram (ECG) monitoring for mildly QT-prolonging drugs. ECG waveforms from the IQ-CSRC study were
Publikováno v:
British Journal of Clinical Pharmacology
Aims Develop a population pharmacokinetics model of tacrolimus in organ transplant recipients receiving twice-daily, immediate-release (IR-T; Prograf) and/or once-daily, prolonged-release (PR-T; Advagraf or Astagraf XL) tacrolimus. Methods Tacrolimus
Autor:
Richard A. Preston, Masataka Katashima, Michaelene Lewand, Akitsugu Takada, Thomas Marbury, Donna Kowalski, James Keirns, Kota Kato, Kenneth C. Lasseter, Tomohiro Kusawake
Publikováno v:
Advances in Therapy
Introduction Amenamevir (ASP2151) is a nonnucleoside human herpesvirus helicase-primase inhibitor that was approved in Japan for the treatment of herpes zoster (shingles) in 2017. This article reports the results of two clinical trials that investiga
Autor:
Dorien Groenendaal-van de Meent, Akitsugu Takada, Tomohiro Kusawake, Donna Kowalski, James Keirns, Masataka Katashima, Martin den Adel, Yoshiaki Ohtsu
Publikováno v:
Advances in Therapy
Introduction Amenamevir (ASP2151) is a nonnucleoside antiherpesvirus compound available for the treatment of varicella–zoster virus infections. In this article we summarize the findings of four phase 1 studies in healthy participants. Methods Four
Autor:
Jay P. Garg, Ogert Fisniku, David Han, Tomasz Wojtkowski, Corrie Howieson, Tong Zhu, James Keirns
Publikováno v:
Clinical Pharmacology in Drug Development. 6:548-555
Peficitinib is an orally administered, once-daily Janus kinase inhibitor currently in development for the treatment of rheumatoid arthritis. It has been shown to be a P-glycoprotein (P-gp) substrate in vitro. The effects of verapamil, an inhibitor of
Autor:
Peter R. Kowey, Takao Yamazaki, Mark Yen, Salim Mujais, Christopher Lademacher, Amit Desai, Tomasz Wojtkowski, B Parker, Robert Townsend, Donna Kowalski, James Keirns, Marlowe J. Schneidkraut
Publikováno v:
Clinical Pharmacology and Therapeutics
The effects of isavuconazole (active moiety of isavuconazonium sulfate) on cardiac ion channels in vitro and cardiac repolarization clinically were assessed in a phase I, randomized, double‐blind study in healthy individuals who received isavuconaz
Autor:
Christine Garnett, Marek Malik, James Keirns, Borje Darpo, Meijian Zhou, Corina Dota, Norman Stockbridge, Georg Ferber
Publikováno v:
The Journal of Clinical Pharmacology. 57:85-95
The revised ICH E14 document allows the use of exposure-response analysis to exclude a small QT effect of a drug. If plasma concentrations exceeding clinically relevant levels is achieved, a positive control is not required. In cases when this cannot
Autor:
Tong Zhu, Kathy Cho, Mark Matson, Taiji Sawamoto, Michaelene Lewand, Udaya Valluri, James Keirns, Kenneth C. Lasseter, Suzanne K. Swan, John Holman, Ying Jun Cao
Publikováno v:
Clinical Pharmacology in Drug Development. 5:435-449
Two randomized, double-blind, placebo-controlled studies are reported that had the objective to evaluate the pharmacokinetics, pharmacodynamics, and safety of ASP015K (peficitinib), a Janus kinase (JAK) inhibitor, in healthy subjects. The single-dose
Autor:
Vicki Santos, James Keirns, Leticia Delgado-Herrera, Ronald Goldwater, Bernhardt Zeiher, Erik E. Karrer, Vishala Chindalore, Atsunori Kaibara, Alan Kivitz, Paul Blahunka, Tong Zhu, Corrie Howieson, Nancy L. Samberg, Stanley Cohen, Robert M. Kernstock, Bolanle Akinlade, Jay P. Garg
Publikováno v:
Clinical Pharmacology in Drug Development. 5:408-425
ASP2408 is a next-generation anti-cytotoxic T lymphocyte antigen-4 fusion protein engineered for improved CD86 binding affinity as a treatment for rheumatoid arthritis (RA). In 72 healthy subjects (n = 6/treatment), ASP2408 was administered as single
Autor:
Charles Benson, Lars Johannesen, Steve Riley, Borje Darpo, Meijian Zhou, Catherine Ortemann-Renon, Christine Garnett, Georg Ferber, Kevin Krudys, RR Stoltz, N Sarapa, Jiang Liu, James Keirns, Cynthia L. Green, Venkateswar Jarugula, B Smith, Corina Dota, Norman Stockbridge
Publikováno v:
Clinical Pharmacology & Therapeutics. 97:326-335
The QT effects of five "QT-positive" and one negative drug were tested to evaluate whether exposure-response analysis can detect QT effects in a small study with healthy subjects. Each drug was given to nine subjects (six for placebo) in two dose lev