This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).
This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of 4 different doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus 300mg Tenofovir disoproxil fumarate (TDF) over 28 days of therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
Research and Education Inc.
San Diego, California, United States
University of Maryland Institute of Human Virology
Baltimore, Maryland, United States
Change in serum hepatitis B virus (HBV) DNA
Time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for GS-7340 8-, 25-, 40 and 120-mg.
Time frame: Up to Week 4
Change in HBV DNA for tenofovir disoproxil fumarate (TDF)
Comparing the short-term antiviral activity of GS-7340 with TDF 300mg. This is measured by time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for TDF.
Time frame: Up to Week 4
Change in HBV DNA of GS-7340 through 28 days of therapy
Time weighted change from baseline to day 29 (DAVG4) in serum HBV DNA (log10 IU/mL)
Time frame: Up to week 4
Pharmacokinetics (PK) of GS-7340 and/or tenofovir (TVF) following single and multiple doses of GS-7340 and TDF
GS-7340 and tenofovir (TFV) PK parameters in plasma will be calculated as applicable: Cmax, Tmax, Clast, Tlast, T1/2, λz, AUC0-t, AUC0-last, AUC0-∞, %AUCexp. PK samples are collected on: * Baseline/Day 1: 0 (predose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose * Additional predose plasma samples will be collected on Days 2, 5, 8, 10, 15, 19, 22, and 29/End of Treatment.
Time frame: Up to week 4
Safety and Tolerability of Therapy
Safety and tolerability is measured by the incidence of adverse events and graded laboratory abnormalities
Time frame: Up to week 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Henry Ford Health System
Detroit, Michigan, United States
Baylor College of Medicine - St. Luke's Episcopal Hospital
Houston, Texas, United States
Monash Medical Centre
Melborne, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Downtown Infectious Diseases Clinic (University of British Columbia)
Vancouver, British Columbia, Canada
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
...and 9 more locations