Overview

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.