This is a research study to evaluate the safety, tolerability and anti-viral activity of GS-9669 in patients with Hepatitis C infection.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
SINGLE
Enrollment
82
Impact Clinical Trials
Los Angeles, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Safety and Tolerability
To evaluate safety and tolerability of escalating multiple oral doses of GS 9669. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs, and 12-lead ECGs at various time points during the study.
Time frame: through 24 weeks of off-treatment follow-up
Antiviral Activity
To evaluate antiviral activity of GS-9669 against HCV in genotype-1a and 1b (GT1a/b) subjects. This will be evaluated using change from baseline in plasma HCV RNA. Reduction in HCV RNA will be summarized as categorical (as \< 1, ≥ 1 to \<2, ≥ 2 to \<3, or ≥ 3 log10 IU/mL) reduction from baseline.
Time frame: through 24 weeks of off-treatment follow-up
Viral Dynamics and Pharmacodynamics
To characterize the viral dynamics of GS-9669. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 3 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-9669.
Time frame: Through 17 days of therapy
composite of Pharmacokinetics
To characterize the plasma PK parameters of GS-9669. The secondary PK endpoints will be evaluated using standard non-compartmental methods. Relevant PK parameters will be determined using standard non-compartmental methods with the linear-logarithmic trapezoidal rule utilizing a PK data analysis program (e.g., WinNonlin®) for GS-9669 as appropriate: Cmax, Tmax, Clast, Tlast, Ctau, λz, AUC0-last, AUCtau, , CL/F, and T½.
Time frame: Through 17 days of therapy
Genotypic Changes
To characterize genotypic changes from baseline in the NS5B coding region of HCV following multiple dose administration of GS-9669 and for up to 24 weeks thereafter
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Impact Clinical Trials
Las Vegas, Nevada, United States
CRI Worldwide
Willingboro, New Jersey, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
Alamo Medical Research
San Antonio, Texas, United States
Lifetree Clinical Research, LC
Salt Lake City, Utah, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Charles River Clinical Services Northwest
Tacoma, Washington, United States
...and 1 more locations
Time frame: through 24 weeks of off-treatment follow-up