Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborators: Duke Clinical Research Institute; ViroChem Pharma

Criteria

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.