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

NCT00623649 | Completed Phase 1 DMC

• 1 other identifier: VCH 916-103
• Study Type: interventional
• Target: 42
• Locations: 3 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults.

  Day 1 visit

• 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

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: VCH 916; Drug: Placebo

Cohort 2

EXPERIMENTAL

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

Drug: VCH 916; Drug: Placebo

Cohort 3

EXPERIMENTAL

VCH-916 300 mg twice daily for three days

Drug: VCH 916; Drug: Placebo

cohort 4

EXPERIMENTAL

VCH-916 400 mg twice daily for three days

Drug: VCH 916; Drug: Placebo

Interventions

VCH 916 DRUG

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

Cohort 1; Cohort 2; Cohort 3; cohort 4

Placebo DRUG

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

Cohort 1; Cohort 2; Cohort 3; cohort 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead
• ViroChem Pharma: collaborator
• Duke Clinical Research Institute: collaborator

Study Sites (5)

The Liver INstitute at Methodist Dallas

Dallas, Texas, 75208, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Fundacion de Investigacion de Diego

Santurce, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• John McHutchison, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 26, 2008
• Study Start: November 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 4, 2014

Record last verified: 2014-02

Locations

PR (1); US (2); CA (2)