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VCH-222

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

VCH-222 · 1 trial · 1 indication

Phase 1 1
NCT00958152Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy SubjectsHepatitis C
COMPLETED30 Analytics
PHASE1COMPLETED
Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
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

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 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 Zealand
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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about VCH-222

What is VCH-222 used for?

VCH-222 is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety and interactions with other medications.

Who makes VCH-222?

VCH-222 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical trials to evaluate the drug's potential in treating Hepatitis C.

What phase is VCH-222 in?

VCH-222 is in Phase 1 clinical development. It is an investigational drug and has not been approved for commercial use. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for Hepatitis C.

What clinical trials is VCH-222 in?

VCH-222 has one completed Phase 1 clinical trial registered as NCT00958152. This was a drug-drug interaction study of VCH-222 and telaprevir in healthy subjects, conducted in New Zealand with 30 participants. The study was randomized, double-blind, and controlled.

Is VCH-222 FDA approved?

VCH-222 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Hepatitis C. The drug has not completed the clinical trials and regulatory review process required for approval, and its safety and efficacy have not been established.