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Journal of Clinical Pharmacology

Jingjing Huang, Ziwei Li, Wu Liang, Bing Chen, Jiong Hu, Wanhua Yang
This study aimed to predict the area under the curve (AUC) of the initial busulfan dose using a test dose with the sparse sampling scheme in adult patients who underwent hematopoietic cell transplant. A test dose of 0.8 mg/kg busulfan was used 2 days before twice-daily intravenous busulfan-based conditioning regimens were administered. The AUC and the clearance (CL) were calculated for both the test dose and the first dose (AUCT , CLT , AUC1, and CL1 ) by noncompartmental analysis. The sparse sampling schemes of the test dose were developed by Bayesian method based on the population pharmacokinetic model...
December 4, 2018: Journal of Clinical Pharmacology
Mohamed-Eslam F Mohamed, Sheryl Trueman, Tian Feng, Alan Friedman, Ahmed A Othman
Upadacitinib is a novel selective oral Janus kinase 1 (JAK) inhibitor being developed for treatment of several inflammatory diseases. Oral contraceptives are anticipated to be a common concomitant medication in the target patient populations. This study was designed to evaluate the effect of multiple doses of upadacitinib on the pharmacokinetics of ethinylestradiol and levonorgestrel in healthy female subjects. This phase I, single-center, open-label, 2-period crossover study evaluated the effect of multiple doses of 30 mg once daily extended-release upadacitinib on the pharmacokinetics of a single oral dose of ethinylestradiol/levonorgestrel (0...
November 30, 2018: Journal of Clinical Pharmacology
Jakub Wroński, Piotr Fiedor
Tumor necrosis factor (TNF) inhibitors significantly improved the treatment options for patients with ankylosing spondylitis. Unfortunately, currently, there is no strategy for sustaining remission of the disease with TNF inhibitors; after discontinuation, a high percentage of patients experience flares in a short time. Therefore, up-to-date, long-term use of TNF inhibitors in patients with ankylosing spondylitis remains necessary. For this reason, the issue of the long-term safety of TNF inhibitors in patients with ankylosing spondylitis raises concerns...
November 26, 2018: Journal of Clinical Pharmacology
Sanjeev Pathak, Bradley Vince, Debra Kelsh, Beatrice Setnik, Narinder Nangia, Lauren DiPetrillo, Matthew D Puhl, Lei Sun, Arielle D Stanford, Elliot Ehrich
Samidorphan is a μ-opioid receptor antagonist in development for the treatment of schizophrenia, in combination with olanzapine, and major depressive disorder, in combination with buprenorphine, at proposed therapeutic doses of samidorphan 10 mg and 2 mg, respectively. A double-blind, double-dummy, active- and placebo-controlled, crossover study evaluated the abuse potential of samidorphan in healthy, nondependent, recreational opioid users. Following a qualification phase, participants were randomized to 1 of 6 treatment sequences of study drugs: placebo, samidorphan (10 or 30 mg), oxycodone (40 mg), pentazocine (30 mg), and naltrexone (100 mg) in a 6 × 6 Williams design...
November 26, 2018: Journal of Clinical Pharmacology
Rocio Osorio, Roger Carrillo-Mezo, Matthew L Romo, Andrea Toledo, Carlos Matus, Iliana González-Hernández, Helgi Jung, Agnès Fleury
Extraparenchymal neurocysticercosis is the most severe form of cysticercosis, and response to treatment is suboptimal. We sought to determine how demographic and clinical characteristics and albendazole sulfoxide concentrations were related to cysticidal treatment response. We conducted a longitudinal study of 31 participants with extraparenchymal vesicular parasites who received the same treatment, albendazole 30 mg/kg/day for 10 days with dexamethasone 0.4 mg/kg/day for 13 days, followed by a prednisone taper...
November 26, 2018: Journal of Clinical Pharmacology
Alberto Jiménez Morales, Mar Maldonado-Montoro, Juan Enrique Martínez de la Plata, Cristina Pérez Ramírez, Abdelali Daddaoua, Carolina Alarcón Payer, Manuela Expósito Ruiz, Carlos García Collado
We evaluated the influence of clinical, biochemical, and genetic factors on response in 142 patients diagnosed with rheumatoid arthritis, of whom 87 patients were treated with tocilizumab (61.26%) and 55 patients were treated with rituximab (38.7%;) according to the variables European League Against Rheumatism (EULAR) response, remission, low disease activity, and improvement in Disease Activity Score, 28 joints (DAS28) at 6, 12, and 18 months. A retrospective prospective cohort study was conducted. Patients carrying the FCGR3A rs396991-TT genotype treated with tocilizumab showed higher EULAR response (OR, 5...
November 20, 2018: Journal of Clinical Pharmacology
Reo Tanoshima, Amna Khan, Agnieszka K Biala, Jessica N Trueman, Britt I Drögemöller, Galen E B Wright, Jafar S Hasbullah, Gabriella S S Groeneweg, Colin J D Ross, Bruce C Carleton
Adverse drug reactions (ADRs) are a major problem in modern medicine, representing up to the fourth-highest cause of mortality. Pharmacogenomic tests are 1 of the most promising methods to tackle the challenge of ADRs. The objective of this study was to analyze the clinical and demographic information of the pan-Canadian active surveillance network, Canadian Pharmacogenomics Network for Drug Safety (CPNDS). Information entered into the database by trained active surveillors between May 15, 2005 and May 9, 2017 was collected and analyzed...
November 19, 2018: Journal of Clinical Pharmacology
Andreas Gille, Danielle Duffy, Michael A Tortorici, Samuel D Wright, Lawrence I Deckelbaum, Denise M D'Andrea
CSL112 (apolipoprotein A-I [human]) is a novel intravenous formulation of plasma-derived apolipoprotein A-I (apoA-I) that enhances cholesterol efflux capacity. Renal impairment is a common comorbidity in acute myocardial infarction patients and is associated with impaired lipid metabolism. The aim of this phase 1 study was to assess the impact of moderate renal impairment on the pharmacokinetic and pharmacodynamic profile of CSL112. Sixteen subjects with moderate renal impairment and 16 age-, sex-, and weight-matched subjects with normal renal function participated in the study...
November 19, 2018: Journal of Clinical Pharmacology
Mario R Sampson, Kelly Y Cao, Paula L Gish, Kyong Hyon, Poonam Mishra, William Tauber, Ping Zhao, Esther H Zhou, Islam R Younis
Although current quetiapine labeling recommends that its dosage should be lowered 6-fold when coadministered with strong cytochrome P450 (CYP)3A inhibitors, a reported case of coma in a patient receiving quetiapine with lopinavir and ritonavir prompted the reevaluation of labeling recommendations for the dosing of quetiapine when coadministered with human immunodeficiency virus (HIV) protease inhibitors. Literature and database (FDA Adverse Event Reporting System and United States Symphony Health Solutions' Integrated Dataverse Database) searches allowed us to identify cases of coma and related adverse events involving the coadministration of quetiapine and HIV protease inhibitors and to estimate the frequency of concomitant use...
November 19, 2018: Journal of Clinical Pharmacology
Ara Koh, Kwan Cheol Pak, Hee Youn Choi, Sunae Ryu, Seung-Eun Choi, Ki Soon Kim, Kyun-Seop Bae, Hyeong-Seok Lim
Amitriptyline is a tricyclic antidepressant that is metabolized mainly by CYP2C19 and CYP2D6 enzymes. Higher plasma levels of amitriptyline and its active metabolite, nortriptyline, are associated with an increased risk of adverse events including anticholinergic effects. The aim of this study was to evaluate the effects of CYP2C19 and CYP2D6 genetic polymorphisms on amitriptyline and nortriptyline pharmacokinetics. Twenty-four Korean healthy adult male volunteers were enrolled in the study after stratification by their CYP2C19 and CYP2D6 genotypes...
November 19, 2018: Journal of Clinical Pharmacology
Julia Winkler, Rik Schoemaker, Armel Stockis
A pediatric population pharmacokinetic model including covariate effects was developed using data from 2 clinical trials in pediatric patients with epilepsy (SP0847 and SP1047). Lacosamide plasma concentration-time data (n = 402) were available from 79 children with body weights ranging from 6 to 76 kg, and a balanced age distribution (6 months to <2 years: n = 14; 2 to <6 years: n = 22; 6 to <12 years: n = 25; 12 to <18 years: n = 18). A single-compartment population pharmacokinetic model with first-order absorption and elimination described the data adequately...
November 14, 2018: Journal of Clinical Pharmacology
Lihong Du, Larissa Wenning, Elizabeth Migoya, Yan Xu, Brendan Carvalho, Kathleen Brookfield, Han Witjes, Rik de Greef, Pisake Lumbiganon, Ussanee Sangkomkamhang, Vitaya Titapant, Lelia Duley, Qian Long, Olufemi T Oladapo
Magnesium sulfate is the standard therapy for prevention and treatment of eclampsia. Two standard dosing regimens require either continuous intravenous infusion or frequent, large-volume intramuscular injections, which may preclude patients from receiving optimal care. This project sought to identify alternative, potentially more convenient, but similarly effective dosing regimens that could be used in restrictive clinical settings. A 2-compartment population pharmacokinetic (PK) model was developed to characterize serial PK data from 92 pregnant women with preeclampsia who received magnesium sulfate...
November 13, 2018: Journal of Clinical Pharmacology
Xiaodong Wang, Jing Wang, Sujata Arora, Lorraine Hughes, Jennifer Christensen, Sharon Lu, Zhi-Yi Zhang
Rolapitant (Varubi) is a neurokinin-1 receptor antagonist approved for the prevention of chemotherapy-induced nausea and vomiting. Rolapitant is primarily metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme. Unlike other neurokinin-1 receptor antagonists, rolapitant is neither an inhibitor nor an inducer of CYP3A4 in vitro. The objective of this analysis was to examine the pharmacokinetics of rolapitant in healthy subjects and assess drug-drug interactions between rolapitant and midazolam (a CYP3A substrate), ketoconazole (a CYP3A inhibitor), or rifampin (a CYP3A4 inducer)...
November 13, 2018: Journal of Clinical Pharmacology
James Gilmore, Alberto Bernareggi
NEPA is the first fixed-combination antiemetic composed of the neurokinin-1 receptor antagonist netupitant (netupitant; 300 mg) and the 5-hydroxytryptamine-3 receptor antagonist palonosetron (palonosetron; 0.50 mg). This study evaluated the pharmacokinetic profiles of netupitant and palonosetron. The pharmacokinetic profiles of both drugs were summarized using data from phase 1-3 clinical trials. netupitant and palonosetron have high absolute bioavailability (63%-87% and 97%, respectively). Their overall systemic exposures and maximum plasma concentrations are similar under fed and fasting conditions...
November 9, 2018: Journal of Clinical Pharmacology
Calvin J Meaney, Spinel Karas, Ben Robinson, Jamie Gaesser, Alan Forrest, Wojciech Krzyzanski, Mandip Panesar, Gauri G Rao
Erythropoiesis-stimulating agents (eg, epoetin alfa) are the primary treatment for anemia in patients with end-stage renal disease . Hemoglobin variability in and out of a narrow target range is common and associated with higher morbidity and mortality risk. More robust erythropoiesis-stimulating agent response metrics are needed to define optimal dosing and their association with clinical outcomes. In this cross-sectional, single-center, retrospective study, 49 patients with end-stage renal disease on hemodialysis were followed over 12 months...
November 9, 2018: Journal of Clinical Pharmacology
Manon Tauzin, Jean-Marc Tréluyer, Rima Nabbout, Thierry Billette de Villemeur, Isabelle Desguerre, Radia Aboura, Ines Gana, Yi Zheng, Sihem Benaboud, Naim Bouazza, Camille Chenevier-Gobeaux, Cécile Freihuber, Déborah Hirt
Valproate is an old-generation antiepileptic drug often used in children. The pharmacokinetics of valproate are noteworthy for a large and difficult to predict interindividual variability in measured serum concentrations and for saturable protein binding. A model-based approach to personalize valproate treatment could be relevant in pediatric patients. The aims of this study were to review all published valproate population pharmacokinetic models in children and assess them by external validation to determine their predictive performance...
November 9, 2018: Journal of Clinical Pharmacology
Hui-Han Kao, Li-Ting Kao, I-Hsun Li, Ke-Ting Pan, Jui-Hu Shih, Yu-Ching Chou, Sheng-Tang Wu
The aim of this study was to investigate the relationship between androgen deprivation therapy and heart failure among prostate cancer patients. This cohort study used the data from the Taiwan Longitudinal Health Insurance Database 2005. In the full cohort study, we identified 1244 prostate cancer patients who had received androgen deprivation therapy as the study cohort and 1806 prostate cancer patients who did not receive androgen deprivation therapy as the comparison cohort. To eliminate potential bias, we performed a propensity score-matched cohort study...
November 7, 2018: Journal of Clinical Pharmacology
Kai-Fan Tsai, Lung-Chih Li, Chien-Ning Hsu, Chih-Che Lin, Yu-Hung Lin, Yu-Fan Cheng, Chih-Chi Wang, Chao-Long Chen
Mammalian targets of rapamycin inhibitors (mTORIs), including sirolimus and everolimus, are used for minimizing calcineurin inhibitors after liver transplantation. However, head-to-head randomized comparisons of these 2 mTORIs are lacking. We assessed the differences in renoprotection and possible mechanisms between sirolimus and everolimus in liver transplant recipients. For this prospective cohort study, we recruited liver transplant recipients whose regimens were switched from tacrolimus to sirolimus or everolimus at a Taiwan medical center...
November 2, 2018: Journal of Clinical Pharmacology
Thanh Bach, Yu Jiang, Xiaoyan Zhang, Guohua An
Although target-mediated drug disposition (TMDD) can occur in both large- and small-molecule compounds, TMDD in small-molecule compounds has received much less attention due to its lower prevalence. To facilitate the identification of nonlinear pharmacokinetics of small-molecule compounds caused by TMDD, a comprehensive simulation was conducted in the current study to provide the general pharmacokinetic features of small-molecule compounds exhibiting TMDD. Various conditions, including single escalating intravenous bolus doses, multiple escalating intravenous bolus doses, and intravenous infusion, were simulated for small-molecule compounds with saturable binding to (1) targets located in tissues and (2) targets located in plasma...
November 2, 2018: Journal of Clinical Pharmacology
Chris Stockmann, Jared Olson, Jahidur Rashid, Lisa Lubsch, David C Young, Adam L Hersh, Adam Frymoyer, Krow Ampofo, Xiaoxi Liu, Yuhuan Wang, Catherine M T Sherwin, Jeffery T Zobell
The prevalence of pulmonary methicillin-resistant Staphylococcus aureus infections in patients with cystic fibrosis (CF) has increased over the last 2 decades. Two concentrations-a postdistributive and a trough-are currently used to estimate the area under the curve (AUC) of vancomycin, an antibiotic routinely used to treat these infections, to achieve the target AUC/minimum inhibitory concentration of ≥400 mg·h/L in ensuring optimal dosing of this drug. This study evaluated precision and bias in estimating vancomycin AUCs obtained either from a population pharmacokinetic (PK) model by using a single trough concentration or from standard PK equation-based 2-point monitoring approach...
October 29, 2018: Journal of Clinical Pharmacology
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