Tse, Susanna Dowty, Martin E Menon, Sujatha Gupta, Pankaj Krishnaswami, Sriram
Published in
Journal of clinical pharmacology
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It is eliminated via multiple pathways including oxidative metabolism (∼70%) and renal excretion (29%). This study aimed to predict the impact of drug-drug interactions and renal or hepatic impairment on tofacitinib ...
Kovacs, Steven J. Ting, Lillian Praestgaard, Jens Sunkara, Gangadhar Sun, Haiying Stein, Daniel S. Tanaka, S. Ken Villano, Stephen
Published in
Antimicrobial Agents and Chemotherapy
Omadacycline is a once-daily oral or intravenous (i.v.) aminomethylcycline antibiotic approved in the United States for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults. Omadacycline pharmacokinetics were characterized in 18 patients with hepatic impairment and ...
Itou, Minoru Fujita, Tomoe Inoue, Kazuaki Uchida, Naoki Takagaki, Takeshi Ishii, Daisuke Kakuyama, Hiroyoshi
Published in
Journal of clinical pharmacology
Ranirestat is an aldose reductase inhibitor hypothesized to improve diabetic neuropathy. An open-label, single-dose, parallel-group study was conducted to compare pharmacokinetic (PK) characteristics of an oral dose of ranirestat across subjects with normal hepatic function and patients with mild and moderate hepatic impairment because ranirestat i...
Rolfo, Christian Isambert, Nicolas Italiano, Antoine Molife, L Rhoda Schellens, Jan H M Blay, Jean-Yves Decaens, Thomas Kristeleit, Rebecca Rosmorduc, Olivier Demlova, Regina
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Published in
British journal of clinical pharmacology
Olaparib, a potent oral poly(ADP-ribose) polymerase inhibitor, is partially hepatically cleared. We investigated the pharmacokinetics (PK) and safety of olaparib in patients with mild or moderate hepatic impairment to provide dosing recommendations. This Phase I open-label study assessed the PK, safety and tolerability of single doses of olaparib 3...
Miyatake, Daisuke Shibata, Tomohisa Toyoshima, Junko Kaneko, Yuichiro Oda, Kazuo Nishimura, Tetsuya Katashima, Masataka Sakaki, Masashi Inoue, Kazuaki Ito, Takayoshi
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Published in
Clinical pharmacology in drug development
Peficitinib (ASP015K) is a novel Janus kinase inhibitor developed for the treatment of rheumatoid arthritis (RA). The impact of hepatic impairment on the peficitinib pharmacokinetic (PK) and safety profile was investigated in non-RA subjects (n = 24) in an open-label, parallel-group, multicenter comparative study in Japan. Subjects received a singl...
Nafziger, Anne N Arscott, Kelly A Cochrane, Kristina Skobieranda, Franck Burt, David A Fossler, Michael J
Published in
Clinical pharmacology in drug development
Oliceridine is a G protein-biased ligand at the μ-opioid receptor in development for treatment of moderate to severe acute pain. A phase 1, open-label, single-dose study investigated the pharmacokinetics and safety of oliceridine 0.5 mg intravenous (IV) in subjects with end-stage renal disease (ESRD, n = 9) versus 1 mg in healthy controls (n = 8). ...
Fukumura, Kazuya Yamada, Tadaaki Yokota, Takaaki Kawasaki, Akira
Published in
Clinical pharmacology in drug development
Naldemedine is a peripherally acting μ-opioid-receptor antagonist for the treatment of opioid-induced constipation. Two phase 1 single-dose studies investigated the pharmacokinetics and safety of a 0.2-mg oral dose of naldemedine in subjects with renal impairment (mild, n = 9; moderate, n = 9; severe, n = 6; and end-stage renal disease, n = 8) or h...
Weersink, Rianne A Burger, David M Hayward, Kelly L Taxis, Katja Drenth, Joost P H Borgsteede, Sander D
Published in
Expert opinion on drug metabolism & toxicology
Introduction: The global burden of cirrhosis is rising, and clinicians increasingly face the challenge of safely prescribing medicines for complications of hepatic disease and comorbidities. Prescribing in patients with cirrhosis is complicated by alterations that can occur in the pharmacology of medicines.Areas covered: This paper provides an over...
Malý, Ondřej Zajak, Ján Hyšpler, Radomír Turek, Zdeněk Astapenko, David Jun, Daniel Váňová, Nela Kohout, Aleš Radochová, Věra Kotek, Jiří
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Published in
Annals of Translational Medicine
Background Liver resection is a surgical procedure associated with a high risk of hepatic failure that can be fatal. One of the key mechanisms involves ischemia-reperfusion damage. Building on the well-known positive effects of hydrogen at mitigating this damage, the goal of this work was to demonstrate the antioxidant, anti-inflammatory, and anti-...
Ng, Juki Duan, W Rachel Marbury, Thomas Schmidt, Jeffrey M Klein, Cheri E
Published in
Clinical pharmacology in drug development
The aim of these studies was to assess the safety and pharmacokinetics of elagolix, an oral nonpeptide gonadotropin-releasing hormone antagonist following oral administration in women with renal or hepatic impairment. Two phase 1 studies were conducted in adult women with normal renal function versus renal impairment (reduced study), and normal hep...