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VCH-222

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Jan 7, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00958152Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy SubjectsPHASE1 COMPLETED 30 — — Aug 1, 2009Jan 1, 2010Jan 7, 20101 New Zealand
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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
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Interventions
NameTypeDescription
VCH-222DRUGCapsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
telaprevirDRUGTablet, Oral, 1125 mg, q12h, Days 18-37
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Eligibility Criteria
Age Range18 Years — 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 Zealand
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Competitive Landscape -Hepatitis C 11 trials
CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Abbott LaboratoriesABT2 — Undisclosed
AbbVie, Inc.ABBV1 — Undisclosed
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