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

April 2, 2014 updated by: Vertex Pharmaceuticals Incorporated

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital - General Campus
    • Quebec
      • Montréal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
  • Puerto Rico
      • Santurce, Puerto Rico, 00909
        • Fundacion De Investigacion de Diego
  • United States
    • Texas
      • Dallas, Texas, United States, 75208
        • The Liver Institute at Methodist Dallas
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
VCH-916 100 mg three times a day (t.i.d.)
Drug: VCH 916
Dose escalation study with a full review of all safety data following each cohort.
Drug: Placebo
Dose escalation study with a full review of all safety data following each cohort.
Experimental: Cohort 2
VCH-916 200 mg (t.i.d.)
Drug: VCH 916
Dose escalation study with a full review of all safety data following each cohort.
Drug: Placebo
Dose escalation study with a full review of all safety data following each cohort.
Experimental: Cohort 3
VCH-916 300 mg twice daily for three days
Drug: VCH 916
Dose escalation study with a full review of all safety data following each cohort.
Drug: Placebo
Dose escalation study with a full review of all safety data following each cohort.
Experimental: cohort 4
VCH-916 400 mg twice daily for three days
Drug: VCH 916
Dose escalation study with a full review of all safety data following each cohort.
Drug: Placebo
Dose escalation study with a full review of all safety data following each cohort.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Time Frame: Day 1 to Day 17 visits
Day 1 to Day 17 visits

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults.
Time Frame: Day 1 visit
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.
Time Frame: Day 1 to Day 4 visits
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.
Time Frame: Day 1 to Day 4 visits
Day 1 to Day 4 visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertex Pharmaceuticals Incorporated

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke Clinical Research Institute
ViroChem Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John McHutchison, MD, Duke Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VCH 916-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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