abstract：:Pain is a troublesome nonmotor symptom of Parkinson's disease (PD). This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate the effect of a dopamine agonist on PD-associated pain as primary outcome. Patients with advanced PD (ie, receiving levodopa) and at least moderate PD-as...

journal_title：Journal of clinical pharmacology

authors： Rascol O,Zesiewicz T,Chaudhuri KR,Asgharnejad M,Surmann E,Dohin E,Nilius S,Bauer L

更新日期：2016-07-01 00:00:00

abstract：:This study evaluated the effects of intravitreal injection of fasudil (IVF), a Rho-kinase inhibitor, in cases of recent-onset nonarteritic anterior ischemic optic neuropathy (NAION). In this interventional case series, 13 eyes of 13 patients diagnosed with NAION within 14 days of onset were included. The affected eyes...

journal_title：Journal of clinical pharmacology

authors： Sanjari N,Pakravan M,Nourinia R,Esfandiari H,Hafezi-Moghadam A,Zandi S,Nakao S,Shah-Heidari MH,Jamali A,Yaseri M,Ahmadieh H

更新日期：2016-06-01 00:00:00

abstract：:This open-label study evaluated apixaban pharmacokinetics, pharmacodynamics, and safety in subjects with mild, moderate, or severe renal impairment and in healthy subjects following a single 10-mg oral dose. The primary analysis determined the relationship between apixaban AUC∞ and 24-hour creatinine clearance (CLcr )...

journal_title：Journal of clinical pharmacology

authors： Chang M,Yu Z,Shenker A,Wang J,Pursley J,Byon W,Boyd RA,LaCreta F,Frost CE

更新日期：2016-05-01 00:00:00

abstract：:The present study was conducted to determine the absolute bioavailability of fimasartan (FMS; Kanarb(®) ) after the single oral administration of a 60-mg tablet or a single 30-mg intravenous (IV) infusion. This investigation was a randomized, single-dose, open-labeled, two-way crossover study of 16 healthy Korean male...

journal_title：Journal of clinical pharmacology

authors： Ghim JL,Paik SH,Hasanuzzaman M,Chi YH,Choi HK,Kim DH,Shin JG

更新日期：2016-05-01 00:00:00

abstract：:Piragliatin is a CYP3A substrate; its inactive metabolite M4, formed through cytosolic reductase, is reversibly metabolized back to piragliatin through CYP3A. The impact of concomitant CYP3A modifiers thus cannot be predicted. Drinking alcohol under fasting conditions is associated with a recognized glucose-lowering e...

journal_title：Journal of clinical pharmacology

authors： Zhi J,Zhai S,Georgy A,Liang Z,Boldrin M

更新日期：2016-05-01 00:00:00

abstract：:X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting in low renal maximum threshold for phosphate reabsorption, low serum phosphate (Pi) and 1,25-dihydroxyvitamin D levels with subsequent development of short stature and skeletal deformities. KRN23 is a ...

journal_title：Journal of clinical pharmacology

authors： Zhang X,Peyret T,Gosselin NH,Marier JF,Imel EA,Carpenter TO

更新日期：2016-04-01 00:00:00

abstract：:The integrated glucose-insulin (IGI) model is a previously published semimechanistic model that describes plasma glucose and insulin concentrations after glucose challenges. The aim of this work was to use knowledge of physiology to improve the IGI model's description of glucose absorption and gastric emptying after t...

journal_title：Journal of clinical pharmacology

authors： Alskär O,Bagger JI,Røge RM,Knop FK,Karlsson MO,Vilsbøll T,Kjellsson MC

更新日期：2016-03-01 00:00:00

abstract：:This multicenter, randomized, open-label, parallel-group, phase-1 study assessed the pharmacokinetics (PK), safety, and tolerability of the investigational intramuscular paliperidone palmitate 3-month (PP3M) formulation in patients with schizophrenia or schizoaffective disorder. A total of 328 patients (men or women, ...

journal_title：Journal of clinical pharmacology

authors： Ravenstijn P,Remmerie B,Savitz A,Samtani MN,Nuamah I,Chang CT,De Meulder M,Hough D,Gopal S

更新日期：2016-03-01 00:00:00

abstract：:The pharmacokinetics (PK) and safety of single-dose buparlisib (30 mg) were assessed in subjects with mild to severe hepatic impairment (n = 6 each) relative to healthy controls (n = 13). Blood samples were collected until 336 hours postdose and evaluated by liquid chromatography tandem mass spectrometry. PK parameter...

journal_title：Journal of clinical pharmacology

authors： Csonka D,Hazell K,Waldron E,Lorenzo S,Duval V,Trandafir L,Kobalava ZD

更新日期：2016-03-01 00:00:00

abstract：:Lomitapide is a microsomal triglyceride transfer protein inhibitor approved as an adjunctive treatment for adult patients with homozygous familial hypercholesterolemia. Lomitapide is extensively metabolized via cytochrome P450 3A (CYP3A) and is a weak CYP3A inhibitor. Two phase 1 open-label, randomized (1:1), 2-arm dr...

journal_title：Journal of clinical pharmacology

authors： Patel G,King A,Dutta S,Korb S,Wade JR,Foulds P,Sumeray M

更新日期：2016-01-01 00:00:00

abstract：:Beverage-drug interactions have remained an active area of research and have been the subject of extensive investigations in the past 2 decades. The known mechanisms of clinically relevant beverage-drug interactions include modulation of the activity of cytochrome P450 (CYP) 3A and organic anion-transporting polypepti...

journal_title：Journal of clinical pharmacology

authors： An G,Mukker JK,Derendorf H,Frye RF

更新日期：2015-12-01 00:00:00

abstract：:The study was undertaken to develop a pharmacokinetic-pharmacodynamic model to characterize efavirenz-induced neuropsychologic impairment, given preexistent impairment, which can be used for the optimization of efavirenz therapy via Monte Carlo simulations. The modeling was performed with NONMEM 7.2. A 1-compartment p...

journal_title：Journal of clinical pharmacology

authors： Bisaso KR,Mukonzo JK,Ette EI

更新日期：2015-11-01 00:00:00

abstract：:Selection of the first dose for neonates in clinical trials is very challenging. The objective of this analysis was to assess if a population pharmacokinetic (PK) model developed with data from infants to adults is predictive of neonatal clearance and to evaluate what age range of prior PK data is needed for informati...

journal_title：Journal of clinical pharmacology

authors： Wang J,Edginton AN,Avant D,Burckart GJ

更新日期：2015-10-01 00:00:00

abstract：:Suvorexant is an orexin receptor antagonist for treating insomnia. The maximum approved dose in the United States and Japan is 20 mg. We evaluated suvorexant effects on respiration during sleep in a randomized, double-blind, 3-period crossover study of healthy adult men (n = 8) and women (n = 4) ≤ 50 years old who rec...

journal_title：Journal of clinical pharmacology

authors： Uemura N,McCrea J,Sun H,Donikyan M,Zammit G,Liu R,Louridas B,Marsilio S,Lines C,Troyer MD,Wagner J

更新日期：2015-10-01 00:00:00

abstract：:The chemoattractant receptor-homologous molecule expressed on T-helper 2 cells (CRTH2) is a G-protein-coupled receptor for prostaglandin D2 , a key mediator in inflammatory disorders. In this randomized, double-blind, placebo-controlled study we investigated the single- and multiple-dose tolerability, pharmacokinetics...

journal_title：Journal of clinical pharmacology

authors： Géhin M,Strasser DS,Zisowsky J,Farine H,Groenen PM,Dingemanse J,Sidharta PN

更新日期：2015-07-01 00:00:00

abstract：:The cancer stem cell paradigm, the epithelial-to-mesenchymal transition and its converse, the mesenchymal-to-epithelial transition, have reached convergence. Implicit in this understanding is the notion that cancer cells can change state, and with such change come bidirectional alterations in motility, proliferative a...

journal_title：Journal of clinical pharmacology

authors： Donnenberg VS,Donnenberg AD

更新日期：2015-06-01 00:00:00

abstract：:A population pharmacokinetic (PPK) model of pomalidomide was developed and the influence of demographic and disease-related covariates on PPK parameters was assessed based on data from 6 clinical trials of pomalidomide (dose range, 0.5-10 mg) in healthy participants (n = 96) and patients with multiple myeloma (MM; n =...

journal_title：Journal of clinical pharmacology

authors： Li Y,Xu Y,Liu L,Wang X,Palmisano M,Zhou S

更新日期：2015-05-01 00:00:00

abstract：:Anemia is a well-known RBV-related event in HCV therapy which is exacerbated by the addition of telaprevir and boceprevir. This retrospective study evaluated and compared ribavirin exposure and parameters able to influence hemoglobin decrease in a large population of patients treated with dual or triple therapy. Patie...

journal_title：Journal of clinical pharmacology

authors： Bodeau S,Nguyen-Khac E,Solas C,Bennis Y,Capron D,Duverlie G,Brochot E

更新日期：2015-05-01 00:00:00

abstract：:Pharmacokinetics (PK) of doripenem was determined during high volume hemodiafiltration (HVHDF) in patients with septic shock. A single 500 mg dose of doripenem was administered as a 1 hour infusion during HVHDF to 9 patients. Arterial blood samples were collected before and at 30 or 60 minute intervals over 8 hours (1...

journal_title：Journal of clinical pharmacology

authors： Tamme K,Oselin K,Kipper K,Low K,Standing JF,Metsvaht T,Karjagin J,Herodes K,Kern H,Starkopf J

更新日期：2015-04-01 00:00:00

abstract：:Faldaprevir is a potent hepatitis C virus (HCV) NS3/4A protease inhibitor and an inhibitor of UDP-glucuronosyltransferase-1A1 (UGT1A1), which is involved in raltegravir clearance. Raltegravir, an HIV integrase inhibitor, may be used in combination with HCV treatment in HCV/HIV co-infected patients. In this open-label,...

journal_title：Journal of clinical pharmacology

authors： Joseph D,Rose P,Strelkowa N,Schultz A,Garcia J,Elgadi M,Huang F

更新日期：2015-04-01 00:00:00

abstract：:Tissue pharmacokinetics and plasma protein binding of colistin have not been described in humans in vivo. Colistin concentrations in plasma, muscle, and subcutis of healthy volunteers were measured by microdialysis after a single dose of 2.5 million IU of colistin methanesulfonate. In vitro microdialysis experiments a...

journal_title：Journal of clinical pharmacology

authors： Matzneller P,Gobin P,Lackner E,Zeitlinger M

更新日期：2015-04-01 00:00:00

abstract：:The confluence of rapid scientific advancements especially in protein engineering and recombinant technology, unmet medical needs, and commercial incentives have led to the development of the next generation of therapeutic proteins. Bispecific antibody constructs are one of the novel strategies that is being pursued, ...

journal_title：Journal of clinical pharmacology

authors： Rathi C,Meibohm B

更新日期：2015-03-01 00:00:00

abstract：:We report population pharmacokinetic, pharmacodynamic, and pharmacokinetic-safety analyses to support phase II/III dose/regimen selection of alisertib, a selective Aurora A kinase (AAK) inhibitor. Phase I studies in adult cancer patients evaluated dosing on Days 1-7 in 21-day cycles or Days 1-21 in 35-day cycles, with...

journal_title：Journal of clinical pharmacology

authors： Venkatakrishnan K,Zhou X,Ecsedy J,Mould DR,Liu H,Danaee H,Fingert H,Kleinfield R,Milton A

更新日期：2015-03-01 00:00:00

abstract：:Astronauts experience Space Motion Sickness requiring treatment with an anti-motion sickness medication, scopolamine during space missions. Bioavailability after oral administration of scopolamine is low and variable, and absorption form transdermal patch is slow and prolonged. Intranasal administration achieves faste...

journal_title：Journal of clinical pharmacology

authors： Wu L,Boyd JL,Daniels V,Wang Z,Chow DS,Putcha L

更新日期：2015-02-01 00:00:00

abstract：:Peginterferon beta-1a was efficacious in a Phase 3 relapsing multiple sclerosis trial, and its safety profile was consistent with other beta interferons. This study evaluated the impact of renal impairment on the pharmacokinetics and pharmacodynamics (neopterin elevation; a biomarker of pharmacological activity induce...

journal_title：Journal of clinical pharmacology

authors： Hu X,Seddighzadeh A,Stecher S,Zhu Y,Goyal J,Matson M,Marbury T,Smith W,Nestorov I,Hung S

更新日期：2015-02-01 00:00:00

abstract：:The objective of this randomized clinical trial was to compare steady-state gestational RBC and plasma folate concentrations in pregnant women supplementing daily with 1.1 mg (regular dose) vs. 5 mg (high dose) folic acid. Thirty-seven pregnant women, who were not previously taking folic acid, were enrolled in this op...

journal_title：Journal of clinical pharmacology

authors： Shere M,Nguyen P,Tam C,Stern S,Kapur B,O'Connor DL,Koren G

更新日期：2015-02-01 00:00:00

abstract：:This multi-center, randomized, double-blind, multiple dose-escalation study was conducted to assess the pharmacokinetics and pharmacodynamics of a newly developed polyethylene glycol (PEG)-conjugated glucagon-like peptide-1 (GLP-1) receptor agonist, PEX168 once weekly in Chinese patients with type 2 diabetes (T2DM). F...

journal_title：Journal of clinical pharmacology

authors： Yang GR,Zhao XL,Jin F,Shi LH,Yang JK

更新日期：2015-02-01 00:00:00

abstract：:The half life (t1/2 ) of teneligliptin is 24.2 hours. Accordingly, we hypothesized that the administration of teneligliptin every other day might improve glycemic control. In this study, we evaluated the effectiveness of the administration of teneligliptin every other day in Japanese patients with type 2 diabetes. Fif...

journal_title：Journal of clinical pharmacology

authors： Kamiko K,Aoki K,Kamiyama H,Taguri M,Shibata E,Ashiya Y,Minagawa F,Shinoda K,Nakajima S,Terauchi Y

更新日期：2015-02-01 00:00:00

abstract：:This study examined warfarin usage for elderly Medicare beneficiaries with atrial fibrillation (AF) who suffered traumatic brain injury (TBI), hip fracture, or torso injuries. Using the 5% Chronic Condition Data Warehouse administrative claims data, this study included fee-for-service Medicare beneficiaries who had a ...

journal_title：Journal of clinical pharmacology

authors： Liu X,Baumgarten M,Smith G,Gambert S,Gottlieb S,Rattinger G,Albrecht J,Langenberg P,Zuckerman I

更新日期：2015-01-01 00:00:00

abstract：:Ofatumumab is a human monoclonal antibody that binds to a unique CD20 epitope on the surface of B lymphocytes, resulting in efficient lysis of CD20-expressing cells via complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. The potential effect of ofatumumab on cardiac repolarization and ...

journal_title：Journal of clinical pharmacology

authors： Jewell RC,Laubscher K,Lewis E,Fang L,Gafoor Z,Carey J,McKeown A,West S,Wright O,Sedoti D,Dixon I,Hottenstein CS,Chan G

更新日期：2015-01-01 00:00:00

abstract：:Vitamin B6 has been known to possess antiemetic effects since 1942. This water soluble compound has several forms in the circulation including pyridoxine, pyridoxal, and pyridoxal phosphate. The active antiemetic form of vitamin B6 is unknown. This was a pre-specified substudy of a randomized, placebo-controlled trial...

journal_title：Journal of clinical pharmacology

authors： Matok I,Clark S,Caritis S,Miodovnik M,Umans JG,Hankins G,Mattison DR,Koren G

更新日期：2014-12-01 00:00:00

abstract：:Research into the distribution of medication errors usually focuses on isolated stages within the medication use process. Our study aimed to provide a novel process-oriented approach to medication incident analysis focusing on medication error chains. Our study was conducted across a 900-bed teaching hospital in Switz...

journal_title：Journal of clinical pharmacology

authors： Huckels-Baumgart S,Manser T

更新日期：2014-10-01 00:00:00

abstract：:Ixekizumab (LY2439821), a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody that selectively binds and neutralizes interleukin (IL) 17A has demonstrated efficacy in the treatment of psoriasis. A population pharmacokinetics-pharmacodynamics model was developed using NONMEM 7.2 to describe the temporal re...

journal_title：Journal of clinical pharmacology

authors： Tham LS,Tang CC,Choi SL,Satterwhite JH,Cameron GS,Banerjee S

更新日期：2014-10-01 00:00:00

abstract：:Tafenoquine is being developed for relapse prevention in Plasmodium vivax malaria. This Phase I, single-blind, randomized, placebo- and active-controlled parallel group study investigated whether tafenoquine at supratherapeutic and therapeutic concentrations prolonged cardiac repolarization in healthy volunteers. Subj...

journal_title：Journal of clinical pharmacology

authors： Green JA,Patel AK,Patel BR,Hussaini A,Harrell EJ,McDonald MJ,Carter N,Mohamed K,Duparc S,Miller AK

更新日期：2014-09-01 00:00:00

abstract：:To determine whether adefovir (ADV) in combination with entecavir (ETV) is more effective than with lamivudine (LAM) in patients with lamivudine-resistant chronic HBV infection, electronic databases were searched through May 10th, 2013 to obtain relevant trials which met the inclusion criteria. Meta-analysis was perfo...

journal_title：Journal of clinical pharmacology

authors： Zeng T,Xu H,Liu JY,Lei Y,Zhong S,Zhou Z

更新日期：2014-09-01 00:00:00

abstract：:Two once-daily rivaroxaban dosing regimens were compared with warfarin for stroke prevention in patients with non-valvular atrial fibrillation in ROCKET AF: 20 mg for patients with normal/mildly impaired renal function and 15 mg for patients with moderate renal impairment. Rivaroxaban population pharmacokinetic (PK)/p...

journal_title：Journal of clinical pharmacology

authors： Girgis IG,Patel MR,Peters GR,Moore KT,Mahaffey KW,Nessel CC,Halperin JL,Califf RM,Fox KA,Becker RC

更新日期：2014-08-01 00:00:00

abstract：:The number of worldwide and Asian multiregional clinical trials (MRCTs) submitted for Japanese New Drug Applications increased markedly between 2009 and 2013, with an increasing number performed for simultaneously submission in the USA, EU, and Japan. Asian studies accounted for 32% of MRCTs (14/44 studies) and had co...

journal_title：Journal of clinical pharmacology

authors： Shirotani M,Kurokawa T,Chiba K

更新日期：2014-07-01 00:00:00

abstract：:The objective of this study was to establish effects of inhaled loxapine on the QTc interval in this randomized, placebo-controlled, double-blind crossover study. Forty-eight healthy volunteers received a single inhaled placebo or 10 mg loxapine. Plasma concentrations of loxapine increased with a median Tmax of 1 minu...

journal_title：Journal of clinical pharmacology

authors： Spyker DA,Voloshko P,Heyman ER,Cassella JV

更新日期：2014-06-01 00:00:00

abstract：:Effective antiretroviral (ARV)-based HIV prevention strategies require optimizing drug exposure in mucosal tissues; yet factors influencing mucosal tissue disposition remain unknown. We hypothesized drug transporter expression in vaginal, cervical, and colorectal tissues is a contributing factor and selected 3 efflux ...

journal_title：Journal of clinical pharmacology

authors： Nicol MR,Fedoriw Y,Mathews M,Prince HM,Patterson KB,Geller E,Mollan K,Mathews S,Kroetz DL,Kashuba AD

更新日期：2014-05-01 00:00:00

abstract：:MC4-NN2-0453 is a novel, long-acting, selective, melanocortin-4-receptor agonist developed for treatment of obesity. This first-human-dose, randomized, double-blind, placebo-controlled trial investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MC4-NN2-0453 in ov...

journal_title：Journal of clinical pharmacology

authors： Royalty JE,Konradsen G,Eskerod O,Wulff BS,Hansen BS

更新日期：2014-04-01 00:00:00