The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
The Liver INstitute at Methodist Dallas
Dallas, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection.
Time frame: Day 1 to Day 17 visits
To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults.
Time frame: Day 1 visit
To establish the relationship between VCH-916 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-916 in adults.
Time frame: Day 1 to Day 4 visits
To study the kinetics of plasma HCV RNA following treatment for up to three(3) days with VCH-916.
Time frame: Day 1 to Day 4 visits
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Fundacion de Investigacion de Diego
Santurce, Puerto Rico