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:1/23/2015)... January 23, 2015 Heptares Therapeutics, the clinical-stage ... announce that the Malcolm Campbell Memorial Prize for ... President of Chemistry), Fiona Marshall (Chief Scientific Officer ... and co-founder) for the seminal contributions to GPCR drug discovery ...
(Date:1/22/2015)... 22, 2015  ResMed Inc. (NYSE: RMD ) today ... for the quarter was $423.0 million, a 10 percent increase ... percent increase on a constant currency basis). Net income was ... quarter ended December 31, 2013. Diluted earnings per share for ...
(Date:1/22/2015)... Increasing sophistication among enterprise buyers of language services ... 2015, says Moravia CMO, Renato Beninatto ... market research firm Common Sense Advisory, 15 percent of ... and localization needs. "From a language industry perspective, this ...
Breaking Medicine Technology:Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 2Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 4ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 2ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 3ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 4ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 5ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 6ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 7ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 8ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 9ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 10ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 11Moravia Sees Single-Sourcing as Key Localization Trend in 2015 2
(Date:1/22/2015)... Hawley, PA (PRWEB) January 22, 2015 Woodloch ... Pocono Mountains, has been selected by TripAdvisor as the number ... and the 6th best in the world for their annual ... online travel community . The website is home to ...
(Date:1/22/2015)... is a famous wedding dress company offering many trendy designs. ... Facebook, Twitter, and Pinterest. The fans will have an opportunity ... every week. , Moreover, the company has extended its 2015 ... homepage for more information. , Angelweddingdress is a ...
(Date:1/22/2015)... Dallas, TX (PRWEB) January 22, 2015 ... the issue of experience and person-centeredness in the long-term ... moving towards action across the continuum. The paper, “The ... the Continuum,” engages perspectives and practices of the patient, ...
(Date:1/22/2015)... Joan Lunden, award-winning American journalist, beloved television host, ... 32nd Annual Miami Breast Cancer Conference planned and ... , shares that “a fast-growing, virulent” cancer in her ... not followed up her clean mammogram with an ultrasound. ...
(Date:1/22/2015)... Four years since the release of their debut ... the marriage of Avasa & Matthew Love – the duo are ... for release through White Swan Records on February 24, 2015. , ... sacred path available to all of us to walk out of ...
Breaking Medicine News(10 mins):Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 2Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 3Health News:Angelweddingdress Invites Its Customers To Follow It On Facebook, Twitter, And Pinterest 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4
... ... distribution underway, PORTLAND, Maine, Dec. 4 Maine,s Good ... simmer sauces for,chicken. The new sauces -- Cacciatore, French Tarragon and ... north Atlantic (MA,ME, RI) and northeast regions (NY, NJ, CT), with ...
... Tubbs Jones released this statement commemorating the 19th,Anniversary of ... was World AIDS Day, a day where we pause,to ... that has proved to,be so devastating to so many ... 65 million people have been infected with,the HIV virus, ...
... 4 /PRNewswire-FirstCall/ - Nventa,Biopharmaceuticals Corporation (TSX:NVN) announced today ... Directors effective as of today to,pursue other interests., ... Board of Directors, commented,on the Board change: "As ... at,Queen,s University, Margot,s knowledge, combined with her experience ...
... Symbol: DND, MISSISSAUGA, ON, Dec. 4 /PRNewswire-FirstCall/ ... it has appealed the position taken by,the U.S. ... letter for,CIP-TRAMADOL ER, using the FDA,s Formal Dispute ... FDA in May 2007 pertaining to its,New Drug ...
... Local ... Pediatrician,s Office, HOUSTON, Dec. 4 AMERIGROUP ... pediatrician Dr.,Muhammad Shaikh at the Bissonet Medical Center in Houston. The ... Community,Care sponsored for the area,s physicians and its providers., Dr. ...
... Aida,Pharmaceuticals (OTC Bulletin Board: AIDA) today ... has been named as a "New and,High-Tech ... New High,Technology Service Centre ("SNHTSC"), a special ... Government. This,designation will allow Rh-Apo2L to have ...
Cached Medicine News:Health News:Good Clean Food's New Line of All-Natural Simmer Sauces for Chicken Hits Market Shelves 2Health News:Good Clean Food's New Line of All-Natural Simmer Sauces for Chicken Hits Market Shelves 3Health News:Tubbs Jones Commemorates World AIDS Day 2Health News:Cipher Appeals FDA's Decision On CIP-TRAMADOL ER 2Health News:AMERIGROUP Community Care Provides 'Doctor's Office Makeover' in Houston 2Health News:Rh-Apo2L Named as One of China's High-Tech Transforming Products by Chinese Government 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: