This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy participants.

开始日期2010-06-01

申办/合作机构

Merck Sharp & Dohme Corp.

ISRCTN44746369 / CompletedN/A

A Phase I/IIa Study Assessing Single and Multiple Doses of Hepatitis C Virus (HCV) Protease Inhibitor IDX320 in Healthy and Genotype 1 HCV-Infected Subjects

开始日期2010-02-08

申办/合作机构

Idenix Pharmaceuticals LLC

100 项与 IDX-320 相关的临床结果

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100 项与 IDX-320 相关的转化医学

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100 项与 IDX-320 相关的专利（医药）

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项与 IDX-320 相关的文献（医药）

2012-05-01·Antiviral Therapy4区 · 医学

Rapid Decline of Viral RNA in Chronic Hepatitis C Patients Treated Once Daily with IDX320: A Novel Macrocyclic HCV Protease Inhibitor

4区 · 医学

Article

作者: Sullivan-Bólyai, John Z ; Mayers, Douglas ; Pietropaolo, Keith ; van Vliet, Andre ; Mazur, Włodzimierz ; Várkonyi, István ; Simon, Krzysztof ; Weegink, Christine J ; Chen, Jie ; Reesink, Hendrik ; Cholewińska-Szymańska, Grażyna ; Temam, Marie-Francoise ; Molles, Jeffrey ; Zhou, Xiao-Jian ; Wiercinska-Drapało, Alicja ; de Bruijne, Joep ; McCarville, Joseph F ; Kapocsi, Judit

Background The addition of direct-acting antivirals to pegylated interferon-α plus ribavirin for the treatment of chronic HCV infection can result in an increased sustained viral response rate and may permit reduction in treatment duration. IDX320 is a potent non-covalent macrocyclic inhibitor of the HCV NS3/4A protease. Methods This was a randomized double-blind placebo-controlled single- and multiple-dose study to assess the safety, tolerability, antiviral activity and pharmacokinetics of IDX320 in healthy volunteers (HV) and patients with chronic HCV genotype 1 infection. HV ( n=48) received single or multiple ascending doses of IDX320. Two HCV-infected patients received a single dose of 200 mg IDX320. Dosages for other HCV-infected patients were as follows: placebo, 50, 100, 200 or 400 mg of IDX320 orally once daily for 3 days ( n=30) or placebo/200 mg of IDX320 twice-daily for 3 days ( n=8). Results In total, 48 HV and 40 HCV-infected patients were enrolled and all completed the study. There were no serious adverse events. The majority of adverse events were of mild or moderate intensity. Pharmacokinetics supported a once-daily dosing regimen. A rapid decline in plasma HCV RNA was observed in all patients. In the multiple-dose study, mean HCV RNA reductions were 2.6, 3.1, 3.1, 3.3 and 3.8 log10 IU/ml after 3 days in the IDX320 50, 100, 200, 400 mg once-daily and 200 mg twice-daily treatment groups, respectively. This compared to a mean HCV RNA reduction of 0.04 log10 in the placebo group. Conclusions Once-daily IDX320 dosing demonstrated potent dose-dependent antiviral activity in treatment-naive HCV genotype-1-infected patients.

2010-10-01·European Journal of Radiology2区 · 医学

Influence of osmolarity of contrast medium and saline flush on computed tomography angiography: Comparison of monomeric and dimeric iodinated contrast media with different iodine concentrations at an identical iodine delivery rate

2区 · 医学

Article

作者: Ki-Ja Lee ; Shoko Doi ; Toshiroh Iwasaki ; Kazutaka Yamada ; Junichiro Shimizu ; Miori Kishimoto ; Yoh-Ichi Miyake

PURPOSETo evaluate the influence of osmolarity of iodinated contrast media and saline flush on the contrast effect in thoracic computed tomography angiography (CTA) at an identical iodine delivery rate (IDR).MATERIALS AND METHODSSeven beagles were used in a cross-over experiment. The contrast media used were iohexol 350 mgI/ml (IOH350; osmolarity 844 mmol/kg) and iodixanol 320 mgI/ml (IDX320; osmolarity 290 mmol/kg). Each contrast medium was administered to groups with and without saline flush at 40.0 mgI/kg/s for all experiments. Dynamic CT scanning was performed at the ninth thoracic vertebra level. The peak value, area under the curve (AUC), and time to peak (TTP) were calculated from the time attenuation curves of the pulmonary artery and aorta.RESULTSThere was no significant difference between IOH350 and IDX320 with or without saline flush in the peak values for the pulmonary artery and aorta. AUC was significantly higher in groups with saline flush for both contrast media and arteries (p<0.05) with no significant difference between contrast media. TTP was significantly longer in groups with saline flush than without saline flush for both contrast media and arteries (p<0.05), with no significant difference between contrast media.CONCLUSIONSThere were no significant differences in the contrast effects of monomeric IOH350 and dimeric IDX320 in thoracic CTA when used at an identical IDR. Moreover, saline flush prolonged the peak duration at 600 mgI/kg.

100 项与 IDX-320 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性丙型肝炎	临床2期	-	Merck Sharp & Dohme Corp.	2010-06-01
丙型肝炎	临床2期	荷兰	Idenix Pharmaceuticals LLC	-
丙型肝炎	临床2期	匈牙利	Idenix Pharmaceuticals LLC	-
丙型肝炎	临床2期	波兰	Idenix Pharmaceuticals LLC	-