Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic HCV Infection



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:5/27/2013
Start Date:November 2012
End Date:August 2014
Contact:Jonathan Bellini
Email:jbellini@gilead.com

Use our guide to learn which trials are right for you!

Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic Hepatitis C Virus Infection


The goal of this study is to assess the safety, tolerability, antiviral activity and
pharmacokinetics of GS-5816 in HCV treatment naïve subjects with genotypes 1-6.


Administration of GS-5816 will be limited to 3 consecutive days to minimize the potential
development of resistance. All subjects will be monitored for up to 48 weeks post-dose to
determine the persistence of viral mutations. Twelve cohorts are planned for the
examination; within each cohort subjects will receive QD doses of GS-5816 with safety,
antiviral activity and pharmacokinetic assessments evaluated at specified time-points during
the study

Inclusion Criteria:

- HCV treatment-naïve adult subjects (18-65 years of age)with chronic HCV infection and
plasma HCV RNA ≥ 5 log10 IU/mL at screening

- Agree to use protocol defined precautions against pregnancy

Exclusion Criteria:

- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,
α1 antitrypsin deficiency, cholangitis)

- Evidence of cirrhosis

- Evidence of current drug abuse

- Screening laboratory results outside the protocol specified requirements
We found this trial at
9
sites
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
?
mi
from
DeLand, FL
Click here to add this to my saved trials
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
?
mi
from
Orlando, FL
Click here to add this to my saved trials
3615 Pacific Ave
Tacoma, Washington 98418
253-593-5304
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Cypress, California 90630
?
mi
from
Cypress, CA
Click here to add this to my saved trials
Kansas City, Missouri 64131
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19139
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Willingboro, New Jersey 08046
?
mi
from
Willingboro, NJ
Click here to add this to my saved trials