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

NCT ID: NCT00623649

Last Updated: 2014-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-10-31

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.

Conditions

HCV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

VCH-916 100 mg three times a day (t.i.d.)

Group Type: EXPERIMENTAL

VCH 916

Intervention Type: DRUG

Dose escalation study with a full review of all safety data following each cohort.

Placebo

Intervention Type: DRUG

Dose escalation study with a full review of all safety data following each cohort.

Cohort 2

VCH-916 200 mg (t.i.d.)

Group Type: EXPERIMENTAL

VCH 916

Intervention Type: DRUG

Dose escalation study with a full review of all safety data following each cohort.

Placebo

Intervention Type: DRUG

Dose escalation study with a full review of all safety data following each cohort.

Cohort 3

VCH-916 300 mg twice daily for three days

Group Type: EXPERIMENTAL

VCH 916

Intervention Type: DRUG

Dose escalation study with a full review of all safety data following each cohort.

Placebo

Intervention Type: DRUG

Dose escalation study with a full review of all safety data following each cohort.

cohort 4

VCH-916 400 mg twice daily for three days

Group Type: EXPERIMENTAL

VCH 916

Intervention Type: DRUG

Dose escalation study with a full review of all safety data following each cohort.

Placebo

Intervention Type: DRUG

Dose escalation study with a full review of all safety data following each cohort.

Interventions

VCH 916

Dose escalation study with a full review of all safety data following each cohort.

Intervention Type: DRUG

Placebo

Dose escalation study with a full review of all safety data following each cohort.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ViroChem Pharma

INDUSTRY

Sponsor Role: collaborator

Duke Clinical Research Institute

OTHER

Sponsor Role: collaborator

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John McHutchison, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Locations

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

Royal Victoria Hospital

Montreal, Quebec, Canada

Fundacion de Investigacion de Diego

Santurce, , Puerto Rico

Countries

United States; Canada; Puerto Rico

Other Identifiers

VCH 916-103

Identifier Type: -

Identifier Source: org_study_id