Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
With
ViroChem Pharma
Duke Clinical Research Institute
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
