超声心动图研究评估新型丙型肝炎病毒 NS5A 抑制剂 GSK2336805 对健康受试者心脏收缩功能的影响。
Echocardiogram study to evaluate the effect of the novel hepatitis C virus NS5A inhibitor GSK2336805 on cardiac contractility in healthy subjects.
机构信息
GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
出版信息
Antimicrob Agents Chemother. 2013 Oct;57(10):5141-3. doi: 10.1128/AAC.00668-13. Epub 2013 Jul 15.
Abstract
GSK2336805 is a hepatitis C virus NS5A inhibitor in clinical development for the treatment of chronic hepatitis C virus infection. This was a single-center, randomized, double-blind, placebo-controlled, two-period crossover study in healthy adults to evaluate the effects of a single 150-mg dose of GSK2336805 on echocardiographic measures of contractility. GSK2336805 had no effect on ejection fraction, and there was no significant correlation between GSK2336805 plasma concentration and ejection fraction. (This study has been registered at Clinicaltrials.gov under registration no. NCT01424540.).
摘要
GSK2336805 是一种处于临床开发阶段的丙型肝炎病毒 NS5A 抑制剂，用于治疗慢性丙型肝炎病毒感染。这是一项在健康成年人中进行的单中心、随机、双盲、安慰剂对照、两周期交叉研究，旨在评估单次 150 毫克剂量 GSK2336805 对收缩功能的超声心动图测量的影响。GSK2336805 对射血分数没有影响，GSK2336805 血浆浓度与射血分数之间也没有显著相关性。（这项研究已在 ClinicalTrials.gov 注册，注册号为 NCT01424540。）
相似文献
1
Echocardiogram study to evaluate the effect of the novel hepatitis C virus NS5A inhibitor GSK2336805 on cardiac contractility in healthy subjects.超声心动图研究评估新型丙型肝炎病毒 NS5A 抑制剂 GSK2336805 对健康受试者心脏收缩功能的影响。
Antimicrob Agents Chemother. 2013 Oct;57(10):5141-3. doi: 10.1128/AAC.00668-13. Epub 2013 Jul 15.
2
Effects of omeprazole and ritonavir on absorption and elimination of the hepatitis C virus NS5A inhibitor GSK2336805 in healthy adults.奥美拉唑和利托那韦对健康成年人中丙型肝炎病毒 NS5A 抑制剂 GSK2336805 吸收和消除的影响。
Clin Pharmacol Drug Dev. 2014 Sep;3(5):338-45. doi: 10.1002/cpdd.104. Epub 2014 Feb 18.
3
Safety, tolerability, pharmacokinetics, and antiviral activity of GSK2336805, an inhibitor of hepatitis C virus (HCV) NS5A, in healthy subjects and subjects chronically infected with HCV genotype 1.在健康受试者和慢性感染 HCV 基因 1 型的受试者中，GSK2336805（一种 HCV NS5A 抑制剂）的安全性、耐受性、药代动力学和抗病毒活性。
Antimicrob Agents Chemother. 2013 Oct;57(10):5037-44. doi: 10.1128/AAC.00910-13. Epub 2013 Jul 29.
4
Pharmacokinetics of hepatitis C virus NS5A inhibitor JNJ-56914845 (GSK2336805) in subjects with hepatic impairment.丙型肝炎病毒NS5A抑制剂JNJ-56914845（GSK2336805）在肝功能损害受试者中的药代动力学。
J Clin Pharmacol. 2015 Sep;55(9):1042-50. doi: 10.1002/jcph.512. Epub 2015 May 25.
5
Efficacy, safety and pharmacokinetics of simeprevir and TMC647055/ritonavir with or without ribavirin and JNJ-56914845 in HCV genotype 1 infection.西米普明与TMC647055/利托那韦联合或不联合利巴韦林以及JNJ-56914845在丙型肝炎病毒1型感染中的疗效、安全性和药代动力学
BMC Gastroenterol. 2017 Feb 10;17(1):26. doi: 10.1186/s12876-017-0580-2.
6
Baseline resistance associated substitutions in HCV genotype 1 infected cohort treated with Simeprevir, Daclatasvir and Sofosbuvir in Brazil.巴西接受simeprevir、达卡他韦和索非布韦治疗的 HCV 基因型 1 感染患者的基线耐药相关替换。
Clin Res Hepatol Gastroenterol. 2020 Jun;44(3):329-339. doi: 10.1016/j.clinre.2019.07.015. Epub 2019 Sep 12.
7
Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin.ABT-450/r-ombitasvir 和利巴韦林联合治疗 HCV。
N Engl J Med. 2014 Apr 24;370(17):1594-603. doi: 10.1056/NEJMoa1315722. Epub 2014 Apr 10.
8
A pilot study examining the safety and tolerability of valacyclovir in veterans with hepatitis C virus/herpes simplex virus type 2 coinfection.一项关于伐昔洛韦在丙型肝炎病毒/2型单纯疱疹病毒合并感染退伍军人中的安全性和耐受性的初步研究。
Am J Med Sci. 2014 Dec;348(6):455-9. doi: 10.1097/MAJ.0000000000000321.
9
Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir.索磷布韦与奥比他韦-帕利瑞韦-利托那韦联用（无论是否联用达沙布韦）时的药物相互作用。
Antimicrob Agents Chemother. 2015 Nov 23;60(2):855-61. doi: 10.1128/AAC.01913-15. Print 2016 Feb.
10
ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis.ABT-450/r-ombitasvir 和 dasabuvir 联合利巴韦林治疗肝硬化合并丙型肝炎。
N Engl J Med. 2014 May 22;370(21):1973-82. doi: 10.1056/NEJMoa1402869. Epub 2014 Apr 11.
本文引用的文献
1
Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial.达卡他韦治疗初治慢性丙型肝炎基因 1 型感染：一项随机、平行分组、双盲、安慰剂对照、剂量探索、2a 期临床试验。
Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.
2
A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C.一项 1 期、随机、安慰剂对照、为期 3 天、剂量递增的研究，评估 NS5A 抑制剂 GS-5885 在基因 1 型丙型肝炎患者中的疗效。
J Hepatol. 2012 Jul;57(1):24-31. doi: 10.1016/j.jhep.2011.12.029. Epub 2012 Feb 5.
3
Multiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1.BMS-790052（一种非结构蛋白 5A 复制复合物抑制剂）在感染 HCV 基因 1 型的患者中的多剂量递增研究。
Hepatology. 2011 Dec;54(6):1956-65. doi: 10.1002/hep.24609.
4
Assessment of the pharmacological effects of inotropic drugs on left ventricular pressure and contractility: an evaluation of the QA interval as an indirect indicator of cardiac inotropism.评估正性肌力药物对左心室压力和收缩性的药理作用：评价QA间期作为心脏变力性的间接指标。
J Pharmacol Toxicol Methods. 2009 Sep-Oct;60(2):193-7. doi: 10.1016/j.vascn.2009.05.008. Epub 2009 Jun 10.
5
Recent in vitro findings of negative inotropy of pantoprazole did not translate into clinically relevant effects on left ventricular function in healthy volunteers.近期关于泮托拉唑负性肌力作用的体外研究结果并未转化为对健康志愿者左心室功能的临床相关影响。
Clin Res Cardiol. 2009 Jun;98(6):391-9. doi: 10.1007/s00392-009-0012-6. Epub 2009 Mar 20.
6
Regulation of hepatitis C virion production via phosphorylation of the NS5A protein.通过NS5A蛋白磷酸化对丙型肝炎病毒粒子产生的调控。
PLoS Pathog. 2008 Mar 21;4(3):e1000032. doi: 10.1371/journal.ppat.1000032.
7
American Society of Echocardiography recommendations for use of echocardiography in clinical trials.美国超声心动图学会关于在临床试验中使用超声心动图的建议。
J Am Soc Echocardiogr. 2004 Oct;17(10):1086-119. doi: 10.1016/j.echo.2004.07.013.
8
Phosphorylation of hepatitis C virus nonstructural protein 5A modulates its protein interactions and viral RNA replication.丙型肝炎病毒非结构蛋白5A的磷酸化作用调节其蛋白相互作用及病毒RNA复制。
Proc Natl Acad Sci U S A. 2004 Aug 31;101(35):13038-43. doi: 10.1073/pnas.0405152101. Epub 2004 Aug 23.
9
Evaluation of the QA interval as an index of cardiac contractility in anaesthetised dogs: responses to changes in cardiac loading and heart rate.评估QA间期作为麻醉犬心脏收缩性指标：对心脏负荷和心率变化的反应。
Cardiovasc Res. 1986 Jun;20(6):444-50. doi: 10.1093/cvr/20.6.444.
10
Reproducibility of quantitative two-dimensional echocardiography.定量二维超声心动图的可重复性
Am Heart J. 1988 Feb;115(2):425-31. doi: 10.1016/0002-8703(88)90491-7.
Zotero 插件