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Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28815729/infusions-are-the-optimal-dosing-method-in-intravenous-adme-studies-rather-than-bolus-dosing
#1
April M Barbour, Michael J Fossler
No abstract text is available yet for this article.
August 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28815653/reply-to-letter-the-use-of-ic50-for-potency-and-mtd-as-objective-in-study-bia-10-2474-by-mattheus-van-iersel-md
#2
Philip Chaikin
No abstract text is available yet for this article.
August 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28815639/safety-tolerability-and-pharmacokinetic-characteristics-of%C3%A2-a-novel-nonopioid-analgesic-vvz-149-injections-in-healthy-volunteers-a-first-in-class-first-in-human-study
#3
Jaeseong Oh, SeungHwan Lee, Anhye Kim, Jangsoo Yoon, Kyungho Jang, Doo H Lee, Sunyoung Cho, Sang Rim Lee, Kyung-Sang Yu, Jae-Yong Chung
VVZ-149, a dual antagonist of GlyT2 and 5HT2 A receptors, is an investigational analgesic with a novel mechanism of action that is currently under early-stage clinical development as an injectable agent for the treatment of postoperative pain. Here, the safety, tolerability, and pharmacokinetics of VVZ-149 injections in healthy male volunteers were explored in a randomized, double-blind, single- and multiple-ascending-dose (SAD and MAD, respectively), placebo-controlled clinical study. Subjects randomly received a 4-hour intravenous infusion of 0...
August 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28815628/the-use-of-ic50-for-potency-and-mtd-as-objective-in-study-bia-10-2474
#4
LETTER
Mattheus Thijs van Iersel
No abstract text is available yet for this article.
August 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28800195/pharmacokinetics-safety-and-tolerability-of-glecaprevir-and-pibrentasvir-in-healthy-white-chinese-and-japanese-adult-subjects
#5
Chih-Wei Lin, Sandeep Dutta, Bifeng Ding, Tianli Wang, Neddie Zadeikis, Armen Asatryan, Jens Kort, Andrew Campbell, Thomas Podsadecki, Wei Liu
Glecaprevir and pibrentasvir are direct-acting antiviral agents being developed as combination therapy for the treatment of chronic hepatitis C virus infection. The aim of the present studies was to assess the effect of race and ethnicity (white, Han Chinese, Japanese) on the pharmacokinetics and safety of multiple oral doses of glecaprevir and pibrentasvir given alone and in combination. Two multiple-dose, single-center, phase 1 studies were conducted in healthy adult male and female subjects (n = 170) of respective Asian and white race/ethnicity...
August 11, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28800166/exposure-response-analysis-of-nivolumab-in-patients-with-previously-treated-or-untreated-advanced-melanoma
#6
Gaurav Bajaj, Manish Gupta, Yan Feng, Paul Statkevich, Amit Roy
No abstract text is available yet for this article.
August 11, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28800141/effects-of-strong-cyp3a-inhibition-and-induction-on-the-pharmacokinetics-of-ixazomib-an-oral-proteasome-inhibitor-results-of-drug-drug-interaction-studies-in-patients-with-advanced-solid-tumors-or-lymphoma-and-a-physiologically-based-pharmacokinetic-analysis
#7
Neeraj Gupta, Michael J Hanley, Karthik Venkatakrishnan, Alberto Bessudo, Drew W Rasco, Sunil Sharma, Bert H O'Neil, Bingxia Wang, Guohui Liu, Alice Ke, Chirag Patel, Karen Rowland Yeo, Cindy Xia, Xiaoquan Zhang, Dixie-Lee Esseltine, John Nemunaitis
At clinically relevant ixazomib concentrations, in vitro studies demonstrated that no specific cytochrome P450 (CYP) enzyme predominantly contributes to ixazomib metabolism. However, at higher than clinical concentrations, ixazomib was metabolized by multiple CYP isoforms, with the estimated relative contribution being highest for CYP3A at 42%. This multiarm phase 1 study (Clinicaltrials.gov identifier: NCT01454076) investigated the effect of the strong CYP3A inhibitors ketoconazole and clarithromycin and the strong CYP3A inducer rifampin on the pharmacokinetics of ixazomib...
August 11, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28783867/absence-of-effect-of-intravaginal-miconazole-clindamycin-nonoxynol-9-and-tampons-on-the-pharmacokinetics-of-an-anastrozole-levonorgestrel-intravaginal-ring
#8
Rüdiger Nave, Stefan Klein, André Müller, Xinying Chang, Joachim Höchel
A study was performed to investigate the effect of an intravaginally administered antimycotic, an antibiotic, and a spermicide plus the co-usage of tampons on the pharmacokinetics (PK) of levonorgestrel (LNG) and anastrozole (ATZ) administered as an intravaginal ring (IVR) releasing 1050 μg ATZ per day and 40 μg LNG per day. In this parallel-group, randomized, open-label study, healthy premenopausal women received an IVR as the main treatment. Comedications were administered on 3 consecutive evenings during treatment with IVR on days 9-11 (group A, 400 mg miconazole; group B, 100 mg clindamycin; group C, 75 mg nonoxynol-9); tampon co-usage (group D) was performed on days 20-23...
August 7, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28783865/a-phase-1-study-to-assess-the-relative-bioavailability-of-two-capsule-formulations-of-ixazomib-an-oral-proteasome-inhibitor-in-patients-with-advanced-solid-tumors-or-lymphoma
#9
Michael J Hanley, Neeraj Gupta, Karthik Venkatakrishnan, Alberto Bessudo, Sunil Sharma, Bert H O'Neil, Bingxia Wang, Helgi van de Velde, John Nemunaitis
The oral proteasome inhibitor ixazomib is approved in multiple countries in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. Two oral capsule formulations of ixazomib have been used during clinical development. This randomized, 2-period, 2-sequence crossover study (Clinicaltrials.gov identifier NCT01454076) assessed the relative bioavailability of capsule B in reference to capsule A in adult patients with advanced solid tumors or lymphoma...
August 7, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28750151/pharmacokinetics-and-safety-of-brexpiprazole-following-multiple-dose-administration-to-japanese-patients-with-schizophrenia
#10
Jun Ishigooka, Shuichi Iwashita, Koushi Higashi, Ei Leen Liew, Yoshihiro Tadori
Brexpiprazole is currently approved in the United States for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder. In Canada, it is approved for the treatment of schizophrenia. This study evaluated the pharmacokinetics (PK) and safety of brexpiprazole in Japanese patients with schizophrenia. This phase 1 study comprised a 14-day multiple-dose administration of brexpiprazole 1, 4, and 6 mg/day (n = 7, 8, and 6, respectively). Plasma concentrations and PK parameters and the influence of CYP2D6 polymorphisms (intermediate metabolizers [IMs] and extensive metabolizers [EMs]) on PK were evaluated...
July 27, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28750149/single-center-evaluation-of-the-pharmacokinetics-and-safety-of-the-angiotensin-ii-receptor-antagonist-azilsartan-medoxomil-in-mild-to-moderate-hepatic-impairment
#11
Caroline Dudkowski, Aziz Karim, Zhen Zhao, Alberto B Alonso, Dyal Garg, Richard A Preston
Azilsartan medoxomil (AZL-M) is a potent angiotensin II receptor blocker that decreases blood pressure in a dose-dependent manner. It is a prodrug that is not detected in blood after its oral administration because of its rapid hydrolysis to the active moiety, azilsartan (AZL). AZL undergoes further metabolism to the major metabolite, M-II, and minor metabolites. The objective of this study was to determine the effect of mild to moderate hepatic impairment on the pharmacokinetics of AZL and its major metabolite...
July 27, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28750137/polymorphism-of-il10-il4-ctla4-and-dao-genes-in-cross-reactive-nonsteroidal-anti-inflammatory-drug-hypersensitivity
#12
Luciana Mabel Ferreira Vasconcelos, Raphael de Oliveira Rodrigues, Andressa Almeida Albuquerque, Gabrielle Dantheias Barroso, Greyce Luri Sasahara, Janaira Fernandes Severo Ferreira, Eudiana Vale Francelino, Cynthia Chester Cardoso, Silvia Helena Barem Rabenhorst, Thereza Lúcia Prata de Almeida, Aparecida Tiemi Nagao-Dias
Our aim was to evaluate genetic polymorphism of molecules involved in immunoregulatory/allergic processes in patients who presented with cutaneous hypersensitivity caused by chemically unrelated nonsteroidal anti-inflammatory drugs. Polymorphisms at IL10 (-1082 G>A), IL4 (-589 C>T), CTLA4 (+49A>G), and DAO (+8956 C>G) genes were studied in 55 cases and 97 controls by the polymerase chain reaction-restriction fragment length polymorphism technique. With regard to the polymorphism at IL10 -1082, higher frequencies of the AG genotype (57% vs 39%) and G allele carriers (70% vs 48%) were found among the patients, indicating a risk effect (odds ratio [OR] = 2...
July 27, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28741301/intravenous-acetaminophen-for-analgesia-back-to-square-one
#13
LETTER
Oscar Fuster-Lluch, Pedro Zapater-Hernández, Manuel Gerónimo-Pardo
No abstract text is available yet for this article.
July 24, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28741299/a-review-of-moxifloxacin-for-the-treatment-of-drug-susceptible-tuberculosis
#14
REVIEW
Anushka Naidoo, Kogieleum Naidoo, Helen McIlleron, Sabiha Essack, Nesri Padayatchi
Moxifloxacin, an 8-methoxy quinolone, is an important drug in the treatment of multidrug-resistant tuberculosis and is being investigated in novel drug regimens with pretomanid, bedaquiline, and pyrazinamide, or rifapentine, for the treatment of drug-susceptible tuberculosis. Early results of these studies are promising. Although current evidence does not support the use of moxifloxacin in treatment-shortening regimens for drug-susceptible tuberculosis, it may be recommended in patients unable to tolerate standard first-line drug regimens or for isoniazid monoresistance...
July 24, 2017: Journal of Clinical Pharmacology
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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