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Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28724200/effect-of-memantine-on-serum-levels-of-neuron-specific-enolase-and-on-the-glasgow-coma-scale-in-patients-with-moderate-traumatic-brain-injury
#1
Majid Mokhtari, Hossein Nayeb-Aghaei, Mehran Kouchek, Mir Mohammad Miri, Reza Goharani, Arash Amoozandeh, Sina Akhavan Salamat, Mohammad Sistanizad
Traumatic brain injury (TBI) is a major cause of disability and death globally. Despite significant progress in neuromonitoring and neuroprotection, pharmacological interventions have failed to generate favorable results. We examined the effect of memantine on serum levels of neuron-specific enolase (NSE), a marker of neuronal damage, and the Glasgow Coma Scale (GCS) in patients with moderate TBI. Patients were randomly assigned to the control group (who received standard TBI management) and the treatment group (who, alongside their standard management, received enteral memantine 30 mg twice daily for 7 days)...
July 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28724195/thyroxin-use-is-associated-with-increased-risk-of-thyroid-cancer-in-patients-with-hypothyroidism
#2
Shih-Han Hung, Shiu-Dong Chung, Herng-Ching Lin
Despite evidence linking thyroxin use and breast cancer, little is known regarding the risk of other cancers with thyroxin use. The purpose of this case-control study was to evaluate the association of thyroid cancer with primary hypothyroidism based on a population-based database. The data for this case-control study were retrieved from the Taiwan Longitudinal Health Insurance Database 2005. We included 1285 patients with thyroid cancer as cases and 3855 sex- and age-matched subjects as controls. We used conditional logistic regression to examine the association of thyroid cancer with previously diagnosed hypothyroidism...
July 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28719721/effect-of-hepatic-impairment-on-eluxadoline-pharmacokinetics
#3
Thomas C Marbury, Jolene Kay Berg, Leonard S Dove, Paul S Covington
No abstract text is available yet for this article.
July 18, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28703903/dosage-optimization-of-nemolizumab-using-population-pharmacokinetic-and-pharmacokinetic-pharmacodynamic-modeling-and-simulation
#4
Tomohisa Saito, Satofumi Iida, Kimio Terao, Yuji Kumagai
Nemolizumab is a humanized anti-interleukin-31 receptor A monoclonal antibody for treating atopic dermatitis, and it especially improves pruritus. The objective of the simulation study was to optimize the dose regimen using a flat dose. The serum nemolizumab concentration and pruritus visual analog scale as an efficacy end point were modeled using the population analysis approach in 299 patients with atopic dermatitis who received placebo or doses between 0.1 and 3 mg/kg as a single dose once every 4 weeks or 2 mg/kg once every 8 weeks...
July 13, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28703316/the-effect-of-renal-impairment-on-the-pharmacokinetics-and-pharmacodynamics-of-ertugliflozin-in-subjects-with-type-2-diabetes-mellitus
#5
V Sahasrabudhe, S G Terra, A Hickman, D Saur, H Shi, M O'Gorman, Z Zhou, D L Cutler
Ertugliflozin is a highly selective and potent inhibitor of the sodium-glucose cotransporter 2 in development for the treatment of type 2 diabetes mellitus. The glycemic efficacy of sodium-glucose cotransporter 2 inhibitors such as ertugliflozin depends on glucose filtration through the kidney. This phase 1, open-label study evaluated the effect of renal impairment on the pharmacokinetics, pharmacodynamics, and tolerability of ertugliflozin (15 mg) in type 2 diabetes mellitus and healthy subjects with normal renal function (estimated glomerular filtration rate not normalized for body surface area ≥90 mL/min) and type 2 diabetes mellitus subjects with mild (60-89 mL/min), moderate (30-59 mL/min), or severe (<30 mL/min) renal impairment (n = 36)...
July 13, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28679023/notable-drug-drug-interaction-between-etizolam-and-itraconazole-in-poor-metabolizers-of-cytochrome-p450-2c19
#6
Takehito Yamamoto, Kenichi Furihata, Akihiro Hisaka, Takashi Moritoyo, Kazuaki Ogoe, Shizuko Kusayama, Keiju Motohashi, Akiko Mori, Takeshi Iwatsubo, Hiroshi Suzuki
In this study, impact of a polymorphism of CYP2C19 on drug-drug interaction (DDI) was examined for etizolam. The effect of itraconazole (a strong CYP3A inhibitor) on the pharmacokinetics of etizolam (a substrate of CYP2C19 and CYP3A) was assessed in both extensive metabolizers (EMs) and poor metabolizers (PMs) of CYP2C19. Sixteen participants (8 EMs and 8 PMs) received a single oral dose of etizolam (0.25 mg) on day 1. The participants ingested itraconazole (200 mg twice a day) on days 2-5. On day 5, participants received an oral dose of etizolam (0...
July 5, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28679021/population-pharmacokinetic-analysis-of-vaginally-and-intravenously-administered-oxytocin-in-postmenopausal-women
#7
Elisabet I Nielsen, Shahla H Al-Saqi, Aino F Jonasson, Kerstin Uvnäs-Moberg
Oxytocin is a neuropeptide hormone used clinically for more than 50 years due to its ability to induce uterine contractions and milk ejection. Vagitocin is a vaginal oxytocin gel developed as a potential treatment of vaginal atrophy in postmenopausal women. The aim of this study was to characterize the oxytocin pharmacokinetics following vaginal and intravenous administration in postmenopausal women. Data from 33 participants enrolled in 2 clinical studies were used in the analysis, with a total of 651 observed oxytocin plasma concentrations, of which 78 were baseline observations, 178 observations following intravenous administration (10 IU), and 395 observations following vaginal administration (100 or 400 IU)...
July 5, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28679020/a-cross-study-analysis-evaluating-the-effects-of-food-on-the-pharmacokinetics-of-rivaroxaban-in-clinical-studies
#8
Liping Zhang, Gary Peters, Lloyd Haskell, Purve Patel, Partha Nandy, Kenneth Todd Moore
US prescribing guidelines recommend that 15- and 20-mg doses of rivaroxaban be administered with food for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for reduction in the risk of recurrence of DVT and PE. In addition, the US prescribing guidelines recommend these doses be administered with an evening meal to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). The purpose of this model-based cross-study comparison was to examine the impact of food, with regard to both meal timing and content, on the pharmacokinetics (PK) of rivaroxaban, using data collected during its clinical development...
July 5, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28650526/a-dual-administration-microtracer-technique-to-characterize-the-absorption-distribution-metabolism-and-excretion-of-14-c-seletalisib-ucb5857-in-healthy-subjects
#9
Eric Helmer, Jean-Marie Nicolas, Jeff Long, Ad F Roffel, Emma Jones, Hugues Chanteux, Nieves Diaz, Holly Garratt, Tjerk Bosje
Phosphoinositide 3 kinases are targets for development of small-molecule inhibitors to disrupt progression of immune-inflammatory diseases. This phase 1 open-label study (Eudract 2014-005353-39) evaluated the safety and relative bioavailability of 2 new seletalisib (UCB5857) formulations (A and B) compared with a reference formulation. Absolute bioavailability (period 1a, n = 6) and disposition and metabolism (period 1b, n = 6) of the reference formulation were evaluated: healthy subjects received 30 mg orally plus ∼20 μg of a (14) C-labeled microtracer (intravenously in 1a, orally in 1b)...
June 26, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28628225/utilization-of-the-bridging-strategy-for-the-development-of-new-drugs-in-oncology-to-avoid-drug-lag
#10
Seiji Kogure, Nobuyuki Koyama, Shinji Hidaka
Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style...
June 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28618035/population-pharmacokinetics-of-imatinib-in-nigerians-with-chronic-myeloid-leukemia-clinical-implications-for-dosing-and-resistance
#11
Babatunde Ayodeji Adeagbo, Tiwalade Adewale Olugbade, Muheez Alani Durosinmi, Rahman Ayodele Bolarinwa, Kayode Ogungbenro, Oluseye Oladotun Bolaji
Imatinib, a tyrosine kinase inhibitor, is the drug of choice for the treatment of chronic myeloid leukemia in Nigeria. Several studies have established interindividual and interpopulation variations in imatinib disposition although no pharmacokinetic study have been conducted in an African population since the introduction of the drug. This study explored a population pharmacokinetic approach to investigate the disposition of imatinib in Nigerians and examined the involvement of some covariates including genetic factors in the variability of the drug disposition with a view to optimize the use of the drug in this population...
June 15, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28618007/an-exploratory-study-in-healthy-male-subjects-of-the-mechanism-of-mirabegron-induced-cardiovascular-effects
#12
Marcel van Gelderen, Matthias Stölzel, John Meijer, Virginie Kerbusch, Christiane Collins, Cees Korstanje
To explore the role of β1 -adrenoceptors (ARs) in the heart rate response to the selective β3 -adrenoceptor agonist mirabegron, 12 young male volunteers received single oral doses of the nonselective β1/2 -AR antagonist propranolol (160 mg), the selective β1 -AR antagonist bisoprolol (10 mg), or placebo on days 1 and 5 of each period in a 3-period crossover study. On day 5, dosing was followed by a supratherapeutic dose of mirabegron (200 mg). Vital signs, impedance cardiography, and plasma renin activity were collected...
June 15, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28618006/lucerastat-an-iminosugar-for-substrate-reduction-therapy-pharmacokinetics-tolerability-and-safety-in-subjects-with-mild-moderate-and-severe-renal-function-impairment
#13
Nicolas Guérard, Christian Zwingelstein, Jasper Dingemanse
Lucerastat, an inhibitor of glucosylceramide synthase, has the potential for substrate reduction therapy in glycosphingolipid storage disorders such as Fabry disease. In pharmacokinetic studies in rats, dogs, and healthy subjects, the main route of elimination was renal. The pharmacokinetics, tolerability, and safety of lucerastat were evaluated in subjects with mild (group A), moderate (group B), and severe (group C) renal impairment. Group D included healthy subjects. Thirty-two subjects (8 per group) were included in this single-center, open-label study and received a single oral dose of 1000 mg lucerastat in groups A and B and 500 mg in groups C and D...
June 15, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28618005/bace1-inhibitor-lanabecestat-azd3293-in-a-phase-1-study-of-healthy-japanese-subjects-pharmacokinetics-and-effects-on-plasma-and-cerebrospinal-fluid-a%C3%AE-peptides
#14
Kei Sakamoto, Shunji Matsuki, Kyoko Matsuguma, Tatsuya Yoshihara, Naoki Uchida, Fumihiko Azuma, Muir Russell, Glen Hughes, Samantha Budd Haeberlein, Robert C Alexander, Susanna Eketjäll, Alan R Kugler
Lanabecestat (AZD3293; LY3314814) is an orally active potent inhibitor of human β-secretase 1 in clinical development for the treatment of Alzheimer disease. In this first Japanese clinical study for an Alzheimer disease intervention to include cerebrospinal fluid (CSF) sampling in Japanese elderly healthy subjects, we report the pharmacokinetics and effects on plasma and CSF amyloid-β (Aβ) peptides of lanabecestat in a phase 1 study involving 40 healthy Japanese subjects (NCT02005211). No safety and tolerability concerns were identified in healthy Japanese subjects exposed to lanabecestat up to the highest doses given, which is consistent with observations in a US phase 1 study of lanabecestat...
June 15, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28614613/population-pharmacokinetic-and-exposure-response-analysis-of-weekly-teriparatide-in-osteoporosis-patients
#15
Atsushi Ose, Masashi Serada, Keiko Yamashita, Kazuyuki Tsurui, Yusuke Tanigawara
Teriparatide is a potent therapeutic agent for the treatment of osteoporosis. One of the aims of this analysis was to develop a population pharmacokinetic (PPK) model to understand the pharmacokinetic characteristics of the once-weekly formulation of teriparatide. Another aim was to develop an exposure-response model to describe the relationship between change in bone mineral density (BMD) and teriparatide exposure after weekly subcutaneous administration. The PPK analysis showed that apparent total body clearance was significantly influenced by estimated creatinine clearance and the presence of osteoporosis...
June 14, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28609567/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-the-novel-crth2-antagonist-bi-1021958-at-single-oral-doses-in-healthy-men-and-multiple-oral-doses-in-men-and-women-with-well-controlled-asthma
#16
Andy Fowler, Rüdiger Koenen, James Hilbert, Jon Blatchford, Dominik Kappeler, Ewald Benediktus, Chester Wood, Abhya Gupta
BI 1021958, a novel antagonist of the chemoattractant-receptor-homologous molecule (CRTH2), targets airway inflammation in asthma by inhibiting prostaglandin binding to CRTH2 receptors. Two phase 1 studies assessed BI 1021958 safety/tolerability and pharmacokinetics (PK)/pharmacodynamics (PD) following single doses in healthy men and multiple doses in men/women with well-controlled asthma. Studies 1 had 2 parts: a placebo-controlled, fixed-sequence, single-blind, single-rising-dose part (n = 56) and a randomized, 2-way crossover, open-label, repeated-dose part studying the food effect on PK/PD (n = 12)...
June 13, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28597922/pharmacokinetic-characterization-and-dose-selection-of-a-novel-sumatriptan-nasal-spray-formulation-dfn-02
#17
Arindam Pal, Anirudh Gautam, Sagar Munjal
This 3-way, single-dose, randomized crossover study evaluated the pharmacokinetics (PK) and dose proportionality of 5-, 10-, and 15-mg doses of intranasal sumatriptan (DFN-02) coformulated with a permeation enhancer (DDM) in 18 healthy adults. The objective was to determine which DFN-02 dose approximates the PK of a 6-mg dose of sumatriptan delivered via subcutaneous injection in the deltoid muscle of the arm. Sumatriptan plasma concentrations peaked with DFN-02 between 10 and 15 minutes postdose, declining thereafter, with a t1/2 of about 2...
June 9, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28597919/an-open-label-dose-finding-study-of-allopurinol-to-target-defined-reduction-in-urate-levels-in-hemodialysis-patients
#18
Elaine Rutherford, Graham Stewart, J Graeme Houston, Alan G Jardine, Patrick B Mark, Allan D Struthers
No abstract text is available yet for this article.
June 9, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28589614/optimization-of-maternal-magnesium-sulfate-administration-for-fetal-neuroprotection-application-of-a-prospectively-constructed-pharmacokinetic-model-to-the-beam-cohort
#19
Kathleen F Brookfield, Mohammed Elkomy, Felice Su, David R Drover, Brendan Carvalho
The aim of the study was to identify the optimal therapeutic maternal magnesium drug exposure and maternal serum concentration to prevent cerebral palsy in the extremely preterm fetus. We applied a previously constructed pharmacokinetic model adjusted for indication to a large cohort of pregnant women receiving magnesium sulfate to prevent cerebral palsy in their preterm offspring at 20 different US academic centers between December 1997 and May 2004. We simulated the population-based individual maternal serum magnesium concentration at the time of delivery and the total magnesium dose for each woman who received magnesium sulfate to determine the relationship between maternal serum magnesium level at the time of delivery and the development of cerebral palsy...
June 6, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28581633/population-pharmacokinetic-analysis-of-zolmitriptan-and-its-metabolite-in-adults-and-adolescents-to-support-dose-selection-in-children-with-migraine
#20
Wangda Zhou, Jianguo Li, Bruce Birmingham, Hongmei Xu, Stefan Lillieborg, Diansong Zhou, Nidal Al-Huniti
Zolmitriptan is a serotonin (5-HT) 1B/1D receptor agonist effective for the treatment of migraine. This analysis aimed to develop a population pharmacokinetic (PK) model for zolmitriptan and its active metabolite in adults and adolescents and provide appropriate dosing regimens to be used in clinical trials for children 6-11 years old. The data from a single-dose clinical study of 5.0-mg zolmitriptan nasal spray (ZNS) conducted in adult and adolescent patients with migraine between migraine attacks was applied...
June 5, 2017: Journal of Clinical Pharmacology
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