A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Faldaprevir and TD 6450 Alone and in Combination With Other Antivirals for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 1 Hepatitis C Virus

Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.

开始日期2016-05-01

申办/合作机构

Trek Therapeutics PBC初创企业

NCT02593162 / Completed临床2期

Phase 2a, Randomized, Double-Blind Study to Investigate the Safety and Efficacy of Faldaprevir in Combination With Ribavirin and TD-6450 for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 4 Hepatitis C Virus

Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.

开始日期2015-10-01

申办/合作机构

Trek Therapeutics PBC初创企业

NCT02116543 / Completed临床1期

A Double-Blinded, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Antiviral Activity of TD-6450, a NS5A Inhibitor, in Treatment Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.

开始日期2014-05-01

申办/合作机构

Theravance Biopharma, Inc.

100 项与 TD-6450 相关的临床结果

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100 项与 TD-6450 相关的转化医学

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100 项与 TD-6450 相关的专利（医药）

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项与 TD-6450 相关的文献（医药）

2023-04-07·Nature communications1区 · 综合性期刊

Safe drugs with high potential to block malaria transmission revealed by a spleen-mimetic screening.

1区 · 综合性期刊

ArticleOA

作者: Gamo, Francisco Javier ; Tarning, Joel ; Buffet, Pierre ; Ndour, Papa Alioune ; Roussel, Camille ; Dumas, Lucie ; Sissoko, Abdoulaye ; Duez, Julien ; Beher, Babette ; Amireault, Pascal ; Gamallo, Pablo ; McNamara, Case W ; Dussiot, Michael ; Hull, Mitchell V ; Fricot-Monsinjon, Aurélie ; Carucci, Mario ; Sanz, Laura Maria ; García-Barbazán, Irene ; Dao, Ming

Malaria parasites like Plasmodium falciparum multiply in red blood cells (RBC), which are cleared from the bloodstream by the spleen when their deformability is altered. Drug-induced stiffening of Plasmodium falciparum-infected RBC should therefore induce their elimination from the bloodstream. Here, based on this original mechanical approach, we identify safe drugs with strong potential to block the malaria transmission. By screening 13 555 compounds with spleen-mimetic microfilters, we identified 82 that target circulating transmissible form of P. falciparum. NITD609, an orally administered PfATPase inhibitor with known effects on P. falciparum, killed and stiffened transmission stages in vitro at nanomolar concentrations. Short exposures to TD-6450, an orally-administered NS5A hepatitis C virus inhibitor, stiffened transmission parasite stages and killed asexual stages in vitro at high nanomolar concentrations. A Phase 1 study in humans with a primary safety outcome and a secondary pharmacokinetics outcome ( https://clinicaltrials.gov , ID: NCT02022306) showed no severe adverse events either with single or multiple doses. Pharmacokinetic modelling showed that these concentrations can be reached in the plasma of subjects receiving short courses of TD-6450. This physiologically relevant screen identified multiple mechanisms of action, and safe drugs with strong potential as malaria transmission-blocking agents which could be rapidly tested in clinical trials.

100 项与 TD-6450 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
丙型肝炎	临床2期	-	Theravance Biopharma, Inc.	-
慢性丙型肝炎基因型 1b	药物发现	美国	Trek Therapeutics PBC初创企业	2016-05-01
慢性丙型肝炎基因型 1b	药物发现	新西兰	Trek Therapeutics PBC初创企业	2016-05-01
慢性丙型肝炎基因型 3	药物发现	美国	Theravance Biopharma, Inc.	2014-05-01
下颌骨发育不良伴A型脂肪代谢障碍	药物发现	美国	Theravance Biopharma, Inc.	2014-02-01
季节性情感障碍	药物发现	美国	Theravance Biopharma, Inc.	2014-02-01