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

HCV Infection Clinical Trial

Official title:

A Phase 1B, Multicentre, Randomized, Double-Blinded, and PLacebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and PK of Multiple Ascending Doses of VCH-916 in the Treatment Naive or Experienced Subjects With Chronic Hep C-Infection.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623649
• Other study ID #: VCH 916-103
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2008
• Last updated: April 2, 2014
• Start date: November 2007
• Est. completion date: October 2008

Study information

• Verified date: February 2014
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HCV Infection
• Infection

Intervention

Drug:
• VCH 916
Dose escalation study with a full review of all safety data following each cohort.
• Placebo
Dose escalation study with a full review of all safety data following each cohort.

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montréal	Quebec
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario
Puerto Rico	Fundacion de Investigacion de Diego	Santurce
United States	The Liver INstitute at Methodist Dallas	Dallas	Texas
United States	Alamo Medical Research	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated	Duke Clinical Research Institute, ViroChem Pharma

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults.		Day 1 visit	No
Secondary	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	No
Secondary	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	No