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MK-6325

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Feb 5, 2015

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01329913Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)PHASE1 COMPLETED 36May 1, 2011Apr 1, 2012Feb 5, 2015 -
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Study Endpoints
Primary Endpoints
Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II)
Up to 15 days after last dose of study drug
Secondary Endpoints
Viral load reduction in GT1 HCV-infected participants (Part I)
7 Days
Viral load reduction in GT3 HCV-infected participants (Part II)
7 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GT1-HCV 200 mgEXPERIMENTAL -
GT1-HCV 400 mgEXPERIMENTAL -
GTI-HCV 800 mgEXPERIMENTAL -
GT3-HCV 200 mgEXPERIMENTAL -
GT3-HCV 400 mgEXPERIMENTAL -
GT3-HCV 800 mgEXPERIMENTAL -
Interventions
NameTypeDescription
MK-6325DRUGTwo 100 mg capsules, orally, once per day for 7 days
Placebo to MK-6325DRUGTwo 100 mg capsules, orally, once per day for 7 days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Body mass index (BMI) of 18 to ≤37 kg/m\^2. * Stable health * No clinically significant abnormality on electrocardiogram (ECG) * Clinical diagnosis of chronic HCV infection (G1 or G3) for at least 6 months and detectable HCV RNA in peripheral blood. Exclusion criteria: * Pre...

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Competitive Landscape -Hepatitis C 11 trials