Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection

A Phase l b/II a, Multicenter, Randomized, Double-Blinded, and Placebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C-Infection

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00911963

Enrollment

Registered

2009-06-03

Start date

2009-04-30

Completion date

2012-09-30

Last updated

2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

VX-222

Brief summary

The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin. The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.

Interventions

DRUGVCH-222 or matching placebo

capsule, oral, 4 doses once daily or twice daily, 3 days

BIOLOGICALpeginterferon alfa-2a

subcutaneous injection, 180 μg, once weekly, 48 weeks

DRUGribavirin

tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male and Female subjects, 18-65 years of age (females non-child bearing potential in Part B) * Have laboratory evidence of HCV infection for 6 months, defined by (1) presence of anti-HCV antibody (Genotype 1a and 1b infection), or (2)documented HCV RNA presence by a sensitive and specific assay and (3 histologic evidence of CHC (Fibrosis on a standardized histological grading system) * Plasma HCV RNA of 100,000 IU/ml * HIV 1 and HIV2 ab seronegative * Body Mass Index (BMI) ≤ 35 kg/m2 BMI * Treatment Naive subjects

Exclusion criteria

* Contraindications to peginterferon or ribavirin therapy * Have evidence of liver cirrhosis, decompensated liver disease, and Child-Pugh score \> 5 * Have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled Type I or II diabetes

Design outcomes

Primary

Measure	Time frame
To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A)	Daily for the first 3 days and at each study visit
To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B)	Week 4 and Week 12
Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B)	Study visits throughout part B

Secondary

Measure	Time frame
To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A)	Study visits throughout Part A
To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)	Time points through Part B

Countries

Argentina, Canada, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026