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Clinical Pharmacokinetics

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https://www.readbyqxmd.com/read/27910037/effect-of-activated-charcoal-on-rivaroxaban-complex-absorption
#1
Edouard Ollier, Sophie Hodin, Julien Lanoiselée, Jean Escal, Sandrine Accassat, Elodie De Magalhaes, Thierry Basset, Laurent Bertoletti, Patrick Mismetti, Xavier Delavenne
OBJECTIVE: To quantify the impact of activated charcoal (AC) on rivaroxaban exposure in healthy volunteers. METHODS: This was an open-label study with an incomplete cross-over design of single-dose rivaroxaban (40 mg) administered alone or with AC in 12 healthy volunteers. The study comprised three treatment periods in randomised sequence, one with rivaroxaban administered alone and two with AC given at 2, 5 or 8 h post-dose. Rivaroxaban plasma concentration was measured in blood samples drawn at 16 time points...
December 2, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27896690/elucidating-the-plasma-and-liver-pharmacokinetics-of-simeprevir-in-special-populations-using-physiologically-based-pharmacokinetic-modelling
#2
Jan Snoeys, Maria Beumont, Mario Monshouwer, Sivi Ouwerkerk-Mahadevan
The disposition of simeprevir (SMV) in humans is characterised by cytochrome P450 3A4 metabolism and hepatic uptake by organic anion transporting polypeptide 1B1/3 (OATP1B1/3). This study was designed to investigate SMV plasma and liver exposure upon oral administration in subjects infected with hepatitis C virus (HCV), in subjects of Japanese or Chinese origin, subjects with organ impairment and subjects with OATP genetic polymorphisms, using physiologically based pharmacokinetic modelling. Simulations showed that compared with healthy Caucasian subjects, SMV plasma exposure was 2...
November 29, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27896689/pharmacokinetics-of-daratumumab-following-intravenous-infusion-in-relapsed-or-refractory-multiple-myeloma-after-prior-proteasome-inhibitor-and-immunomodulatory-drug-treatment
#3
Pamela L Clemens, Xiaoyu Yan, Henk M Lokhorst, Sagar Lonial, Nedjad Losic, Imran Khan, Richard Jansson, Tahamtan Ahmadi, Kristen Lantz, Honghui Zhou, Thomas Puchalski, Xu Steven Xu
Daratumumab is a CD38 monoclonal antibody recently approved for the treatment of multiple myeloma (MM). We report daratumumab pharmacokinetic data from GEN501, a phase I/II dose-escalation (0.005-24 mg/kg) and dose-expansion (8 or 16 mg/kg) study, and SIRIUS, a phase II study (8 or 16 mg/kg), in relapsed or refractory MM. Noncompartmental analysis was conducted to characterize daratumumab pharmacokinetics, and, in both studies, daratumumab exhibited nonlinear pharmacokinetic characteristics. Decreasing daratumumab clearance with increasing dose suggests saturation of target-mediated clearance at higher dose levels, whereas decreasing clearance over time with repeated dosing may be due to tumor burden reductions as CD38-positive cells are eliminated...
November 29, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27878567/drug-interactions-between-peficitinib-an-orally-administered-once-daily-janus-kinase-inhibitor-and-rosuvastatin-in-healthy-subjects
#4
Tong Zhu, Barbara Parker, Tomasz Wojtkowski, Tetsuya Nishimura, Jay P Garg, David Han, Ogert Fisniku, James Keirns
BACKGROUND AND OBJECTIVE: Peficitinib is an orally administered, once-daily Janus kinase inhibitor in development for the treatment of rheumatoid arthritis. Peficitinib and its major metabolite H2 inhibit the hepatic uptake transporter organic anion transporting polypeptide 1B1 (OATP1B1) in vitro. This article reports a clinical study evaluating the effects of peficitinib on the pharmacokinetics of rosuvastatin, a substrate for the OATP1B1 transporter, and vice versa. METHODS: In an open-label, single-sequence clinical study, 24 healthy adults of East Asian and non-East Asian origin received a single dose of rosuvastatin 10 mg on days 1 and 10...
November 22, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27878566/pharmacokinetic-and-pharmacodynamic-properties-of-faster-acting-insulin-aspart-versus-insulin-aspart-across-a-clinically-relevant-dose-range-in-subjects-with-type-1-diabetes-mellitus
#5
Tim Heise, Kirstine Stender-Petersen, Ulrike Hövelmann, Jacob Bonde Jacobsen, Leszek Nosek, Eric Zijlstra, Hanne Haahr
BACKGROUND: Absorption of current rapid-acting insulins is too slow for patients with diabetes mellitus to achieve optimal postprandial glucose control. Faster-acting insulin aspart (faster aspart) is insulin aspart in a new formulation with faster early absorption. We compared the pharmacokinetic/pharmacodynamic properties of faster aspart and insulin aspart across a clinically relevant dose range. METHODS: In this randomised, double-blind, crossover trial, 46 subjects with type 1 diabetes mellitus received single subcutaneous doses of faster aspart and insulin aspart at 0...
November 22, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27873172/erratum-to-open-flow-microperfusion-as-a-dermal-pharmacokinetic-approach-to-evaluate-topical-bioequivalence
#6
Manfred Bodenlenz, Katrin I Tiffner, Reingard Raml, Thomas Augustin, Christian Dragatin, Thomas Birngruber, Denise Schimek, Gerd Schwagerle, Thomas R Pieber, Sam G Raney, Isadore Kanfer, Frank Sinner
No abstract text is available yet for this article.
November 21, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27832452/clinical-pharmacokinetics-and-pharmacodynamics-of-antihyperglycemic-medications-in-children-and-adolescents-with-type-2-diabetes-mellitus
#7
REVIEW
Fatemeh Akhlaghi, Kelly L Matson, Amir Hooshang Mohammadpour, Meghan Kelly, Asieh Karimani
The incidence of type 2 diabetes mellitus (T2DM) among children and adolescents has been rising. This condition is associated with obesity, and it's prevalence is higher among minority or female youth. Lifestyle modification including diet and exercise is only successful in a small proportion of patients; therefore, pharmacotherapy approaches are needed to treat T2DM among youth. Currently, in the USA, only metformin and insulin are approved for the treatment of T2DM in children. However, several antihyperglycemic agents including exenatide, glimepiride, glyburide, liraglutide, pioglitazone, and rosiglitazone are also used off-label in this population...
November 10, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27830564/acknowledgement-to-referees
#8
(no author information available yet)
No abstract text is available yet for this article.
November 9, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27815868/a-prospective-population-pharmacokinetic-study-on-morphine-metabolism-in-cancer-patients
#9
Astrid W Oosten, João A Abrantes, Siv Jönsson, Maja Matic, Ron H N van Schaik, Peter de Bruijn, Carin C D van der Rijt, Ron H J Mathijssen
BACKGROUND: Oral and subcutaneous morphine is widely used for the treatment of cancer-related pain; however, solid pharmacokinetic data on this practice are lacking. Furthermore, it is largely unknown which factors contribute to the variability in clearances of morphine and its metabolites and whether morphine clearance is related to treatment outcome. METHODS: Blood samples from 49 cancer patients treated with oral and/or subcutaneous morphine were prospectively collected and were used to develop a population pharmacokinetic model for morphine, morphine-3-glucuronide (M3G) and morphine-6-glucuronide (M6G)...
November 5, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27815867/author-s-reply-to-srinivas-modeling-the-relationship-between-exposure-to-abiraterone-and-prostate-specific-antigen-dynamics-in-patients-with-metastatic-castration-resistant-prostate-cancer
#10
LETTER
https://www.readbyqxmd.com/read/27815866/comment-on-modeling-the-relationship-between-exposure-to-abiraterone-and-prostate-specific-antigen-dynamics-in-patients-with-metastatic-castration-resistant-prostate-cancer
#11
LETTER
https://www.readbyqxmd.com/read/27783363/influence-of-fcgr3a-158v-f-genotype-and-baseline-cd20-antigen-count-on-target-mediated-elimination-of-rituximab-in-patients-with-chronic-lymphocytic-leukemia-a-study-of-filo-group
#12
Mira Tout, Anne-Laure Gagez, Stéphane Leprêtre, Valérie Gouilleux-Gruart, Nicolas Azzopardi, Alain Delmer, Mélanie Mercier, Loïc Ysebaert, Kamel Laribi, Hugo Gonzalez, Gilles Paintaud, Guillaume Cartron, David Ternant
BACKGROUND AND OBJECTIVES: Rituximab is an anti-CD20 monoclonal antibody approved in the first-line treatment of patients with chronic lymphocytic leukemia (CLL). Rituximab pharmacokinetics shows a time dependency possibly related to changes in the target antigen amount over time. The purpose of this study was to quantify the influence of both CD20 antigenic mass and the FcγRIIIA genetic polymorphism on rituximab pharmacokinetics in CLL. METHODS: Rituximab pharmacokinetics was described in 118 CLL patients using a semi-mechanistic model including a latent target antigen turnover, which allowed the estimation of rituximab target-mediated elimination in addition to the endogenous clearance...
October 25, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27766562/a-physiologically-based-pharmacokinetic-model-to-predict-human-fetal-exposure-for-a-drug-metabolized-by-several-cyp450-pathways
#13
Maïlys De Sousa Mendes, Gabrielle Lui, Yi Zheng, Claire Pressiat, Deborah Hirt, Elodie Valade, Naïm Bouazza, Frantz Foissac, Stephane Blanche, Jean-Marc Treluyer, Saik Urien, Sihem Benaboud
BACKGROUND: Pregnant women and their fetuses are exposed to numerous drugs; however, they are orphan populations with respect to the safety and efficacy of drugs. Therefore, the prediction of maternal and fetal drug exposure prior to administration would be highly useful. METHODS: A physiologically-based pharmacokinetic (PBPK) model for nevirapine, which is metabolized by the cytochrome P450 (CYP) 3A4, 2B6 and 2D6 pathways, was developed to predict maternal and fetal pharmacokinetics (PK)...
October 21, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27753003/clinical-pharmacokinetics-and-pharmacodynamics-of-febuxostat
#14
Bishoy Kamel, Garry G Graham, Kenneth M Williams, Kevin D Pile, Richard O Day
Febuxostat is a xanthine oxidoreductase inhibitor that has been developed to treat chronic gout. In healthy subjects, the pharmacokinetic parameters of febuxostat after multiple oral dose administration include an oral availability of about 85 %, an apparent oral clearance (CL/F) of 10.5 ± 3.4 L/h and an apparent volume of distribution at steady state (V ss/F) of 48 ± 23 L. The time course of plasma concentrations follows a two-compartment model. The initial half-life (t ½) is approximately 2 h and the terminal t ½ determined at daily doses of 40 mg or more is 9...
October 17, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27753002/clinical-determinants-of-target-non-attainment-of-linezolid-in-plasma-and-interstitial-space-fluid-a-pooled-population-pharmacokinetic-analysis-with-focus-on-critically-ill-patients
#15
Iris K Minichmayr, André Schaeftlein, Joseph L Kuti, Markus Zeitlinger, Charlotte Kloft
OBJECTIVES: We aimed to assess linezolid pharmacokinetics in the plasma and interstitial space fluid (ISF) of patients with sepsis, diabetic foot infections or cystic fibrosis and healthy volunteers. The impacts of joint characteristics and disease on plasma and target-site exposure were to be identified together with the benefit of dose intensification in critically ill patients. METHODS: Rich plasma (n = 1598) and ISF concentrations in subcutaneous adipose (n = 1430) and muscle tissue (n = 1089) measured by microdialysis were pooled from three clinical trials with 51 individuals receiving 600 mg of intravenous and oral linezolid...
October 17, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27744580/lack-of-clinical-pharmacokinetic-studies-to-optimize-the-treatment-of-neglected-tropical-diseases-a-systematic-review
#16
Luka Verrest, Thomas P C Dorlo
INTRODUCTION: Neglected tropical diseases (NTDs) affect more than one billion people, mainly living in developing countries. For most of these NTDs, treatment is suboptimal. To optimize treatment regimens, clinical pharmacokinetic studies are required where they have not been previously conducted to enable the use of pharmacometric modeling and simulation techniques in their application, which can provide substantial advantages. OBJECTIVES: Our aim was to provide a systematic overview and summary of all clinical pharmacokinetic studies in NTDs and to assess the use of pharmacometrics in these studies, as well as to identify which of the NTDs or which treatments have not been sufficiently studied...
October 15, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27743205/population-pharmacokinetics-of-a-novel-once-every-3-months-intramuscular-formulation-of-paliperidone-palmitate-in-patients-with-schizophrenia
#17
Mats O Magnusson, Mahesh N Samtani, Elodie L Plan, E Niclas Jonsson, Stefaan Rossenu, An Vermeulen, Alberto Russu
OBJECTIVES: Our objective was to characterize the population pharmacokinetics of paliperidone after intramuscular administration of its long-acting 3-month formulation palmitate ester at various doses and at different injection sites (deltoid and gluteal muscles). METHODS: This retrospective analysis included pooled data from 651 subjects from one phase I study (single injection of the 3-month formulation) and one phase III study (multiple injections of both 1- and 3-month formulations)...
October 14, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27734291/clinical-pharmacokinetics-and-pharmacodynamics-of-cabozantinib
#18
Steven A Lacy, Dale R Miles, Linh T Nguyen
Cabozantinib inhibits receptor tyrosine kinases involved in tumor angiogenesis and metastasis. The capsule formulation (Cometriq(®)) is approved for the treatment of progressive metastatic medullary thyroid cancer at a 140-mg free base equivalent dose. The tablet formulation (Cabometyx™, 60-mg free base equivalent dose) is approved for the treatment of renal cell carcinoma following anti-angiogenic therapy. Cabozantinib displays a long terminal plasma half-life (~120 h) and accumulates ~fivefold by day 15 following daily dosing based on area under the plasma concentration-time curve (AUC)...
October 12, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27722855/pharmacokinetics-and-pharmacodynamics-of-lurasidone-hydrochloride-a-second-generation-antipsychotic-a-systematic-review-of-the-published-literature
#19
William M Greenberg, Leslie Citrome
Lurasidone hydrochloride, a benzisothiazol derivative, is a second-generation (atypical) antipsychotic agent that has received regulatory approval for the treatment of schizophrenia in the US, Canada, the EU, Switzerland, and Australia, and also for bipolar depression in the US and Canada. In addition to its principal antagonist activity at dopamine D2 and serotonin 5-HT2A receptors, lurasidone has distinctive 5-HT7 antagonistic activity, and displays partial agonism at 5-HT1A receptors, as well as modest antagonism at noradrenergic α2A and α2C receptors...
October 8, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27722854/disease-drug-interaction-of-sarilumab-and-simvastatin-in-patients-with-rheumatoid-arthritis
#20
Eun Bong Lee, Nikki Daskalakis, Christine Xu, Anne Paccaly, Barry Miller, Roy Fleischmann, Inga Bodrug, Alan Kivitz
INTRODUCTION: Elevated interleukin (IL)-6 occurs in patients with active rheumatoid arthritis (RA), which has been shown to lead to a decrease in cytochrome P450 (CYP) enzyme activity and alterations in drug concentrations metabolized by CYP. IL-6 signaling blockade by IL-6 receptor (IL-6R) antagonists may reverse this effect of IL-6 and restore CYP activity. This study evaluated the pharmacokinetic profile of simvastatin (a CYP3A4 substrate) before and 1 week after a single dose of sarilumab (a human monoclonal antibody [mAb] blocking the IL-6Rα) in patients with RA, to assess potential interaction...
October 8, 2016: Clinical Pharmacokinetics
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