Abstracts tagged "pharmacokinetics"

Abstract Number: 738 • 2015 ACR/ARHP Annual Meeting
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the BCL-2 Inhibitor Venetoclax (ABT-199) in a Phase 1 Single and Multiple Ascending Dose Study in Female Patients with Systemic Lupus Erythematosus
Peng Lu¹, Roy Fleischmann², Craig Curtis³, Stanislav Ignatenko⁴, Monali Desai⁵, Shekman L. Wong⁵, Kristie M. Grebe¹, Jiewei Zeng⁵, Jeroen Medema⁵ and James Stolzenbach⁵, ¹AbbVie Inc., Worcester, MA, ²University of Texas Southwestern Medical Center, Dallas, TX, ³Compass Research Center, Orlando, FL, ⁴Charité Research Organization, Berlin, Germany, ⁵AbbVie Inc., North Chicago, IL
Background/Purpose: Apoptosis is needed to eliminate auto-reactive T and B cells during immune responses; failure of elimination is important in development of systemic lupus erythematosus…
Abstract Number: 1643 • 2015 ACR/ARHP Annual Meeting
Modified-Release Formulation of Tofacitinib: Evaluation of Pharmacokinetics Compared with Immediate-Release Tofacitinib and Impact of Food
Manisha Lamba¹, Rong Wang¹, Tracey Fletcher², Christine Alvey¹, Joseph Kushner¹ and Thomas Stock², ¹Pfizer Inc, Groton, CT, ²Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. A modified-release (MR) formulation has been designed to enable once daily (QD)…
Abstract Number: 2351 • 2015 ACR/ARHP Annual Meeting
A Study to Evaluate the Pharmacodynamics, Pharmacokinetics and Safety of Arhalofenate in Combination with Febuxostat When Treating Hyperuricemia Associated with Gout
Alexandra Steinberg, Yun-Jung Choi, Robert Martin, Charles McWherter and Pol Boudes, Cymabay Therapeutics, Newark, CA
Background/Purpose: Arhalofenate is a novel Urate-Lowering Anti-Flare Therapy (ULAFT) for the treatment of gout. It lowers serum uric acid (sUA) by blocking URAT1, a tubular…
Abstract Number: 2416 • 2015 ACR/ARHP Annual Meeting
Pharmacokinetics, Safety, and Tolerability of Tofacitinib in Pediatric Patients from Six to Less Than Eighteen Years of Age with Juvenile Idiopathic Arthritis
Hermine I. Brunner¹, Nicolino Ruperto², Nikolay Tzaribachev³, Zbigniew Zuber⁴, Elena Koskova⁵, Ivan Foeldvari⁶, Eizbieta Smolewska⁷, Gerd Horneff⁸, Charles Mebus⁹, Umberto Conte¹⁰, Rong Wang⁹, Christine Alvey⁹, Manisha Lamba⁹, Anasuya Hazra¹¹, Daniel Lovell¹² and Alberto Martini¹³, ¹Pediatric Rheumatology Collaborative Study Group, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Istituto G. Gaslini, Pediatria II, PRINTO, Genoa, Italy, ³Pediatric Rheumatology, Bad Bramstedt, Germany, ⁴St Louis Children’s Hospital ODS Rheumatology and Neurology, Krakow, Poland, ⁵Institute of Rheumatic Diseases, Piestany, Slovakia, ⁶Hamburger Zentrum für Kinder-und Jugendrheumatologie, Hamburg, Germany, ⁷Department of Pediatric Cardiology and Rheumatology, Medical University of Lodz, Lodz, Poland, ⁸Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin, Germany, ⁹Pfizer Inc, Groton, CT, ¹⁰Pfizer Inc, New York, NY, ¹¹Pfizer Inc, Collegeville, PA, ¹²Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ¹³Istituto G. Gaslini, Pediatria II, PRINTO, and University of Genoa, Genoa, Italy
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of adult patients with rheumatoid arthritis (RA). We report the pharmacokinetics (PK), safety and…
Abstract Number: 2755 • 2015 ACR/ARHP Annual Meeting
Evaluating Pharmacokinetic Predictors of Tofacitinib Clinical Response in Rheumatoid Arthritis
Manisha Lamba¹, Daniel E. Furst², Ara Dikranian³, Martin Dowty¹, Matthew M Hutmacher⁴, Daniela Conrado¹, Thomas Stock⁵, Chudy Nduaka⁵ and Sriram Krishnaswami¹, ¹Pfizer Inc, Groton, CT, ²Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, ³San Diego Arthritis Medical Clinic, San Diego, CA, ⁴Ann Arbor Pharmacometrics Group, Ann Arbor, MI, ⁵Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. A modified-release (MR) formulation to provide a once-daily (QD) dosing alternative to…
Abstract Number: 1492 • 2014 ACR/ARHP Annual Meeting
Safety and Tolerability of NNC01140006, an Anti-IL-21 Monoclonal Antibody, at Multiple s.c. Dose Levels in Patients with Rheumatoid Arthritis
Frank Wagner¹, Birte Skrumsager² and Sergey Fitilev³, ¹Charité Research Org GmbH, Berlin, Germany, ²Novo Nordisk A/S, Søborg, Denmark, ³Department of Clinical Pharmacology, Municipal Clinic #2, Moscow, Russia
Background/Purpose A phase 1, randomised, double-blind, placebo-controlled, dose-escalation trial was conducted to assess the safety and tolerability of the anti-IL-21-antibody NNC0114-0006, in patients with active…
Abstract Number: 1478 • 2014 ACR/ARHP Annual Meeting
Pharmacokinetics, Bioavailability and Safety of a Modified-Release Once-Daily Formulation of Tofacitinib in Healthy Volunteers
M. Lamba¹, R. Wang¹, T. Fletcher², C. Alvey¹, A. Hazra¹, J. Kushner¹, J. Larmann¹ and T. Stock², ¹Pfizer Inc, Groton, CT, ²Pfizer Inc, Collegeville, PA
Background/Purpose: Tofacitinib is an oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA). The efficacy and safety of an immediate-release (IR) formulation…

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