Sheng, Jennifer Zhang, Jason Baudelet, Christine Roy, Amit
Published in
Journal of clinical pharmacology
Nivolumab 240 mg every 2 weeks is approved in China by the National Medical Product Agency for squamous cell carcinoma of the head and neck and gastric cancer, based on population pharmacokinetic (PPK) analyses and benefit-risk assessment of safety/efficacy in solid tumors, including Chinese and global populations. The aim of this assessment was to...
Al-Kofahi, Mahmoud Oetting, William S Schladt, David P Remmel, Rory P Guan, Weihua Wu, Baolin Dorr, Casey R Mannon, Roslyn B Matas, Arthur J Israni, Ajay K
...
Published in
Journal of clinical pharmacology
Genetic variation in the CYP3A4 and CYP3A5 (CYP3A4/5) genes, which encode the key enzymes in tacrolimus metabolism, is associated with tacrolimus clearance and dose requirements. Tacrolimus has a narrow therapeutic index with high intra- and intersubject variability, in part because of genetic variation. High tacrolimus clearance and low trough con...
Feng, Sheng Bo, Qingyan Coleman, Hugh A Charoin, Jean Eric Zhu, Mingfen Xiao, Jim Jin, Yuyan
Published in
Journal of clinical pharmacology
Coproporphyrins (CP-I and CP-III) in plasma are considered potential markers for assessing liver organic anion-transporting polypeptide transporter OATP1B activity and monitoring OATP1B-mediated drug-drug interactions (DDIs) in clinical settings. However, the effect of altered renal clearance (CLrenal ) on CP-I and CP-III plasma exposure has rarely...
Kretschmar, Melanie Suleiman, Ahmed Abbas Krause, Petra Albrecht, Uwe Stein, Raimund Rubenwolf, Peter Fuhr, Uwe Taubert, Max
Published in
Journal of clinical pharmacology
Oxybutynin is a racemic anticholinergic drug used for the symptomatic treatment of detrusor overactivity. The formation of active metabolites related to tolerability problems depends on the route of administration. The objective of this evaluation was to develop a pharmacokinetic model for oral/intravesical administration as the basis for simulatio...
Ghim, Jong-Lyul Chin, May Chien Jung, Jinah Lee, Jiwon Kim, Seokuee Kim, Bongtae Song, Geun Seog Choi, Young-Kyung Shin, Jae-Gook
Published in
Journal of clinical pharmacology
This clinical trial was conducted to evaluate the pharmacokinetics and pharmacodynamics of tegoprazan when coadministered with amoxicillin/clarithromycin in healthy subjects. Cohort 1 was an open-label, randomized multiple-dose study to evaluate the mutual interaction of tegoprazan and amoxicillin/clarithromycin on the disposition of 3 tested drugs...
Ly, Neang Zheng, Yanan Griffiths, Janet M van der Merwe, Rene Agoram, Balaji Parnes, Jane R Roskos, Lorin
Published in
Journal of clinical pharmacology
Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial cytokine involved in asthma pathogenesis. In the phase 2b PATHWAY study (ClinicalTrials.gov identifier: NCT02054130), tezepelumab significantly reduced exacerbations in adults with severe, uncontrolled asthma. We used pharmacokinetic (PK) and pharmaco...
Magee, Mindy Slater, Jill Mannino, Frank Ackerman, Peter Llamoso, Cyril Moore, Katy
Published in
Journal of clinical pharmacology
The oral prodrug fostemsavir (GSK3684394, formerly BMS-663068) is an antiretroviral treatment for HIV-1. Fostemsavir is metabolized to its active moiety, temsavir, a first-in-class HIV-1 attachment inhibitor that binds to the viral envelope glycoprotein 120. Long-term antiretroviral therapy, the resulting longer life expectancy, and/or certain coin...
Haverty, Thomas Wyatt, David J Porter, Kaela M Leubitz, Andi Banks, Kate Goodyer, Paul Hu, Ming-Yi
Published in
Journal of clinical pharmacology
The aim of this study was to assess the pharmacokinetics (PK) and safety of ELX-02 in a renally impaired population and apply these findings to the individualized dosing of patients with nephropathic cystinosis. This phase 1 renal impairment (RI; mild, moderate, or severe), single-dose, PK, and safety evaluation included 6 participants assigned to ...
McPhail, Brooks T Emoto, Chie Butler, Dawn Fukuda, Tsuyoshi Akinbi, Henry Vinks, Alexander A
Published in
Journal of clinical pharmacology
Chronic intrauterine exposure to psychoactive drugs often results in neonatal opioid withdrawal syndrome (NOWS). When nonpharmacologic measures are insufficient in controlling NOWS, morphine, methadone, and buprenorphine are first-line medications commonly used to treat infants with NOWS because of in utero exposure to opioids. Research suggests th...
Melchior, Meggane Dingemanse, Jasper Alatrach, Abir Feldkamp, Thorsten Sidharta, Patricia N Géhin, Martine
Published in
Journal of clinical pharmacology
Sinbaglustat (ACT-519276), a brain-penetrating inhibitor of glucosylceramide synthase and nonlysosomal glucosylceramidase, is developed as a new therapy for lysosomal storage disorders. In the first-in-human study, sinbaglustat was primarily excreted unchanged in urine. This study was conducted to evaluate the effect of mild, moderate, and severe r...
