Status:
COMPLETED
Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
ViroChem Pharma
Duke Clinical Research Institute
Conditions:
HCV Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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., vi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00623649
Start Date
November 1 2007
End Date
October 1 2008
Last Update
April 4 2014
Active Locations (5)
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1
The Liver INstitute at Methodist Dallas
Dallas, Texas, United States, 75208
2
Alamo Medical Research
San Antonio, Texas, United States, 78215
3
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
4
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1