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VCH-222

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Trials Updated: Mar 10, 2014

VCH-222 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment79

FDA Designations

No designations recorded

VCH-222 clinical trials

VCH-222 · 2 trials · 1 indication

Phase 1 2
NCT00958152Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy SubjectsHepatitis C
COMPLETED30 Analytics
NCT00911963Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C InfectionHepatitis C
COMPLETED49 Analytics
PHASE1COMPLETED
Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
Hepatitis CUnlock trial analytics
PHASE1COMPLETED
Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events
Day 47 safety assessment
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 Endpoints

Pharmacokinetic parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of VCH-222 at steady-state in plasma in the presence and absence of telaprevir at steady-state
Day 37 pharmacokinetic assessment
Pharmacokinetics parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of telaprevir at steady-state in plasma in the presence and absence of VCH-222 at steady-state
Day 37 pharmacokinetic assessment
To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A)
Study visits throughout Part A
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Part AEXPERIMENTALThis will be a 4 dose escalation study comparing VCH-222 to placebo treatment.
Part BEXPERIMENTALVCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks

Interventions

NameTypeDescription
VCH-222DRUGCapsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
telaprevirDRUGTablet, Oral, 1125 mg, q12h, Days 18-37
VCH-222 or matching placeboDRUGcapsule, oral, 4 doses once daily or twice daily, 3 days
peginterferon alfa-2aBIOLOGICALsubcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirinDRUGtablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males, and/or healthy females of non-childbearing potential, aged 18 to 55 years (inclusive) * Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight \> 50 kg Exclusion Criteria: * Women of child bearing potential * Subjects positive for Hepatitis B, He...

Countries:New ZealandUnited StatesArgentinaCanadaPuerto Rico
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Competitive Landscape -Hepatitis C 13 trials

Top 1 of 4 competitors

CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir
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Frequently asked questions about VCH-222

What is VCH-222 used for in hepatitis C?

VCH-222 is an investigational small molecule developed by Vertex Pharmaceuticals for the treatment of hepatitis C, a chronic viral infection of the liver. It has been studied in Phase 1 clinical trials in both healthy volunteers and subjects with chronic hepatitis C infection. It is not an approved therapy.

Who makes VCH-222?

VCH-222 is being developed by Vertex Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker VRTX. Vertex sponsored the Phase 1 clinical program evaluating the compound in hepatitis C, including drug-drug interaction and multiple ascending dose studies.

What phase is VCH-222 in?

VCH-222 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The studies enrolled a combined total of 79 participants. VCH-222 is investigational and has not been approved by the FDA for any indication.

What clinical trials has VCH-222 been studied in?

VCH-222 has been evaluated in two completed Phase 1 trials. NCT00958152 was a drug-drug interaction study of VCH-222 and telaprevir in 30 healthy subjects in New Zealand. NCT00911963 examined the pharmacokinetics of multiple ascending doses in 49 subjects with chronic hepatitis C infection across the United States, Argentina, Canada, and Puerto Rico.

How was VCH-222 studied in the hepatitis C trials?

Both VCH-222 trials were randomized, double-blind, and controlled. NCT00958152 enrolled 30 healthy volunteers aged 18 and older in New Zealand to assess drug-drug interactions with telaprevir. NCT00911963 enrolled 49 adults with chronic hepatitis C infection to evaluate multiple ascending dose pharmacokinetics. No biomarker-based patient selection was used.