HCV Infection
Conditions
Brief summary
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.
Interventions
DRUGVCH 916
Dose escalation study with a full review of all safety data following each cohort.
DRUGPlacebo
Dose escalation study with a full review of all safety data following each cohort.
Sponsors
ViroChem Pharma
Duke Clinical Research Institute
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Males and females 18 to 60 years of age * No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3 * Subject's liver disease is stable with ALT values \< 5 X ULN * Serologic evidence of detectable plasma HCV-RNA of ≥ 100,000 IU/ml at screening * Documented HCV Genotype 1 chronic hepatitis C. * Judged to be in good health on the basis of medical history and physical examination * All other hematology and clinical chemistry must be within normal limits or show no clinically significant abnormalities. * Be treatment-naïve or experienced. * For female subjects, must not be pregnant or breastfeeding and must be postmenopausal, surgically sterile, abstinent, or using two proven methods of birth control. * Sexually active male subjects, must be practicing acceptable methods of contraception during the treatment period * Female subjects of childbearing potential must have a negative serum ß-HCG pregnancy test at screening and a negative urine pregnancy test on Day 1 before the first dose of study drugs. * Agree not to participate in other clinical trials for the duration of his/her participation in this clinical trial.
Exclusion criteria
* Be participating in any other clinical studies or have participated in another clinical trial within the last 30 days before study drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study). * Be actively taking hard illicit drugs within 12 months prior to the screening visit or alcohol. * Have a Child-Pugh score \> than 5. * Have evidence of liver cirrhosis including histological evidence of hepatic cirrhosis on any liver biopsy. * Have any cause of liver disease other than chronic hepatitis C-infection * Active or malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma). * Have clinically significant electrocardiogram abnormalities and/or cardiovascular dysfunction within the previous 6 months * Have significant renal, pulmonary, gastrointestinal absorption, or neurological diseases, or neoplasia. * Have a history of psychiatric disorders determined by the investigator to contraindicate therapy. * Have uncontrolled Type 1 or Type II diabetes. * Antinuclear antibody titer ≥1:320. * Coinfection with hepatitis B and/or HIV 1 or HIV 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Day 1 to Day 17 visits |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults. | 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. | 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. | Day 1 to Day 4 visits |
Countries
Canada, Puerto Rico, United States
Outcome results
None listed