Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
- Registration Number
- NCT00623649
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 VCH 916 VCH-916 100 mg three times a day (t.i.d.) Cohort 1 Placebo VCH-916 100 mg three times a day (t.i.d.) Cohort 3 Placebo VCH-916 300 mg twice daily for three days cohort 4 VCH 916 VCH-916 400 mg twice daily for three days Cohort 2 Placebo VCH-916 200 mg (t.i.d.) Cohort 3 VCH 916 VCH-916 300 mg twice daily for three days cohort 4 Placebo VCH-916 400 mg twice daily for three days Cohort 2 VCH 916 VCH-916 200 mg (t.i.d.)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults. Day 1 visit
Trial Locations
- Locations (5)
Fundacion de Investigacion de Diego
🇵🇷Santurce, Puerto Rico
Royal Victoria Hospital
🇨🇦Montréal, Quebec, Canada
The Liver INstitute at Methodist Dallas
🇺🇸Dallas, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada