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

This study has been completed.
Sponsor:
Collaborators:
ViroChem Pharma
Duke Clinical Research Institute
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00623649
First received: February 14, 2008
Last updated: April 2, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
HCV Infection
Drug: VCH 916
Drug: Placebo
Phase 1

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

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults. [ Time Frame: Day 1 visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623649

Locations
United States, Texas
The Liver INstitute at Methodist Dallas
Dallas, Texas, United States, 75208
Alamo Medical Research
San Antonio, Texas, United States, 78215
Canada, Ontario
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Royal Victoria Hospital
Montréal, Quebec, Canada, H3A 1A1
Puerto Rico
Fundacion de Investigacion de Diego
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
ViroChem Pharma
Duke Clinical Research Institute
Investigators
Principal Investigator: John McHutchison, MD Duke Clinical Research Institute
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00623649     History of Changes
Other Study ID Numbers: VCH 916-103
Study First Received: February 14, 2008
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

ClinicalTrials.gov processed this record on July 20, 2014