Recent Updates
Recently added Catalysts

Comparator: MK7009

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Aug 25, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00518622Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)PHASE1 COMPLETED 40Jul 1, 2007Sep 1, 2008Aug 25, 2015 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety and Tolerability of MK7009
14 days after completion of study therapy

Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication

Antiviral Activity of MK7009
Baseline and Day 8

Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8

Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL25 mg b.i.d. MK7009
2EXPERIMENTAL75 mg b.i.d. MK7009
3EXPERIMENTAL250 mg b.i.d. MK7009
4EXPERIMENTAL500 mg b.i.d. MK7009
5EXPERIMENTAL700 mg b.i.d. MK7009
6EXPERIMENTAL125 mg q.d. MK7009
7EXPERIMENTAL600 mg q.d. MK7009
8EXPERIMENTALPlacebo
Interventions
NameTypeDescription
Comparator: MK7009DRUGDepending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Comparator: PlaceboDRUGMK7009 Placebo
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject is a man or a woman aged 18 to 55 years of age. * Subject has chronic Hepatitis C * Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period Exclusion Criteria: * Patient has evidence of advanced liver disease. * Patie...

Unlock Eligibility Criteria
Competitive Landscape -Hepatitis C 11 trials