Navigation Links
Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C
Date:10/3/2007

onically infected with HCV genotype 1. This adaptive Phase 1 study is comprised of three parts:

Part 1 is a single ascending dose study of R7128 conducted in 46 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability and pharmacokinetics of R7128 following single ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128. Results from the single ascending dose portion of the study indicated that all doses of R7128 studied (500 mg to 9000 mg) were generally safe and well-tolerated. All patients completed the study, and none experienced gastrointestinal adverse events or serious adverse events during the study. No hematological or laboratory abnormalities of clinical significance were noted.

Part 2 is a multiple ascending dose study of R7128 conducted in 40 patients chronically-infected with HCV genotype 1 who previously failed interferon therapy. The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily (QD) or twice- daily (BID) dosing for 14 days. The secondary objective is to assess antiviral activity by measuring the change in HCV RNA. Preliminary data from the multiple ascending dose portion of the study indicated that R7128 demonstrated potent, dose-dependent antiviral activity in four patient cohorts receiving 750 mg or 1500 mg administered either once-daily or twice-daily for 14 days as monotherapy. Patients receiving 1500 mg BID demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of viral rebound in any dose cohort during the 14 days of dosing. R7128 was generally safe and well tolerated. There were no serious adverse events, no adverse events requiring dose modification, no dose-related gastrointestinal adverse events and no clinically significant changes in hematologic or other laboratory parameters.

Part 3 is a multi-center, observ
'/>"/>

SOURCE Pharmasset, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Pharmasset Presents Clevudine and Racivir Data at the International HIV Drug Resistance Workshop
2. Pharmasset Announces Clevudine and Hepatitis C Presentations at EASL
3. New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir
4. Phase II Results Show Once-Daily Dosing of Human GLP-1 Analog Liraglutide, Brings Patients to A1c Target
5. New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir
6. ChemGenex Reports Successful Personalized Dosing of Quinamed at ASCO
7. ChemGenex Reports Successful Personalized Dosing of Quinamed at ASCO
8. Celator Pharmaceuticals Study Shows Anti-Tumor Activity in Cancer Patients Treated with Therapy Based on Ratiometric Dosing
9. PC-DAC:Exendin-4 Phase I/II Multiple-Dose Study Preliminary Results Demonstrate Safety and Efficacy at Once-Weekly Dosing
10. Sunesis Pharmaceuticals Presents SNS-314 Aurora Kinase Inhibitor Data Showing Broad Anti-Tumor Activity, Dosing Flexibility
11. Active Biotechs I-3D Micro-dosing Clinical Trial Concluded
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... Corporation , a neurodiagnostics medical device company based in ... Forcht Dagi , MD, DmedSc, MPH, MBA, FACS, FRCSEd  was ... " Teo Forcht Dagi is an experienced leader with ... said Remis Bistras , President and CEO of Vittamed. ... entrepreneurial expertise to our Board." Dr. Dagi is ...
(Date:8/29/2014)... , Aug. 29, 2014 Diseases largely eradicated ... generation ago are returning. Measles was declared eliminated in ... 2014 as of August 15—the highest incidence in 20 ... health department declared whooping cough a problem of ... getting sick and dying from these preventable diseases—in part ...
(Date:8/29/2014)... -- ChemImage will present a workshop focused on hyperspectral ... Science Society,s 22 nd International Symposium on ... .  Forensic Scientists will be in attendance ... can bring to examination procedures. ... Development at ChemImage, will host a workshop during ...
Breaking Medicine Technology:Vittamed Adds Prominent Neurosurgeon and Venture Capitalist T. Forcht Dagi to Board of Directors 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 3ChemImage to Discuss Hyperspectral Imaging for Forensic Investigation at the ANZFSS 22nd International Symposium on the Forensic Sciences 2ChemImage to Discuss Hyperspectral Imaging for Forensic Investigation at the ANZFSS 22nd International Symposium on the Forensic Sciences 3
... The Department of Justice, on behalf of the U.S. Food ... permanent injunction against generic drug manufacturer Ranbaxy in the ... filed against Ranbaxy Laboratories, Ltd., an Indian corporation; its ... Dale Adkisson, senior vice president, head of global quality, ...
... Fine Chemicals LLC (AFC), a wholly owned subsidiary of ... today that is has been granted Registration as a ... Agency (DEA). AFC has been involved in ... under a Researcher,s License from the DEA.  Recent facilities ...
Cached Medicine Technology:Department of Justice files consent decree of permanent injunction against Ranbaxy 2Department of Justice files consent decree of permanent injunction against Ranbaxy 3Department of Justice files consent decree of permanent injunction against Ranbaxy 4AMPAC Fine Chemicals Expands Into Controlled Substance Manufacturing 2AMPAC Fine Chemicals Expands Into Controlled Substance Manufacturing 3AMPAC Fine Chemicals Expands Into Controlled Substance Manufacturing 4
(Date:8/30/2014)... (PRWEB) August 30, 2014 One of the ... era is the gluten-free diet. Originally meant for sufferers of ... a catchall for people who are looking to get healthier ... not only is this kind of information erroneous, it also ... problems because of a drastic change in their food ...
(Date:8/30/2014)... 30, 2014 LiveStreamingFitness.com, a company dedicated to ... healthy lifestyle resources, is proud to announce it has been ... at home fitness solutions by ABC’s Good Morning America. ... on ABC’s Good Morning America, “Live Streaming Fitness is the ... your day by streamlining your workout…to boot camp at Life ...
(Date:8/30/2014)... (PRWEB) August 30, 2014 “In 2013, a ... The Jones Firm says in a recently released article on ... person was injured in an auto accident every 12 minutes, ... minutes,” they continue. “Based on the 2013 statistics, between now ... vehicle collision.” , The threat of an auto accident is ...
(Date:8/30/2014)... Boston, MA (PRWEB) August 30, 2014 ... and nurse practitioner locum tenens company , announces ... open September 1, 2014. Barton Associates is headquartered in ... Enfield, CT; Keene, NH; and Jupiter, FL. ... response to the increasing demand for healthcare providers. The ...
(Date:8/30/2014)... The first multidisciplinary recommendations on the management of ... are published today in EP Europace . ... the European Heart Rhythm Association (EHRA), the Acute ... of Percutaneous Cardiovascular Interventions (EAPCI), all of the ... of the task force, said: "Sudden cardiac death ...
Breaking Medicine News(10 mins):Health News:“What is Gluten: Three Things You Need to Know Before Adopting a Gluten-Free Diet” Reveals What Readers Need to Know About the Benefits of a Strict Gluten Diet - Vinamy 2Health News:LiveStreamingFitness.com is New Trend In Fitness 2Health News:Startling Washington Auto Accident Statistics Discussed In Recently Released Article By The Jones Firm 2Health News:Barton Associates Announces New Office Location in Austin, TX 2Health News:First multidisciplinary recommendations on management of arrhythmias in ACS patients 2
... blood clot that develops deep in the vein. It can ... ,People who require prolonged bed rest are vulnerable ... patients in intensive care and patient on catheters are at ... in critically ill patients , a small pulmonary embolism, which ...
... high levels of amino acid are associated with an ... been // associated with an increased risk of heart ... to be associated with homocystinuria, a rare disease characterized ... high levels have also been found to be associated ...
... consisting of periods of growth (anagen), regression (catagen), ... activation of ?-catenin in // telogen-phase adult hair ... Scientists have discovered that the transient activation of ... growth. ,Previous work has implicated Wnt/?-catenin ...
... Not all vitamins may be good for you. A new ... antioxidant vitamins, such as // E, C and beta carotene, ... ,Some studies have shown that vitamin E prevented the ... cells. Thus, the liver destroyed fewer of the bad lipoproteins. ...
... new type of stent that releases medication appears safe ... heart disease patients, // a process known as restenosis. ... drug everolimus. The drug acts by inhibiting cell reproduction ... similar drug-eluting stents, the one used in this study ...
... a recent study neurosurgeons say they are now convinced ... ,Studies in the past have suggested wearing helmets during ... the risk of skull base and cervical-spine (or neck) ... findings prompted researchers to study whether helmets harm or ...
Cached Medicine News:Health News:New Hair in 15 Days Could Now Be A Possibility Say Researchers 2
... contains primers and a FAM-labeled probe that ... gene. In addition, this ASR contains primers, ... internal control sequence. This ASR requires an ... Red reporter dyes such as the Cepheid ...
...
Reptilase-Time from Bothrops atrox...
Thrombin Activatable Fibrinolysis Inhibitor Assay Kit...
Medicine Products: