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MK-7680

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jul 27, 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
CONTROLLED
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02269059Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)PHASE1 COMPLETED 13Dec 1, 2014Apr 1, 2015Jul 27, 2015 -
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Study Endpoints
Primary Endpoints
Change from baseline in HCV viral load
Day 1: predose, 2, 4, 8, 12, and 24 hours postdose; Days 3, 4, 5, and 6: predose; and Day 7: predose, 4, 12, 24, and 48 hours postdose
Number of participants experiencing an adverse event (AE)
Up to 21 days
Number of participants discontinuing from study therapy due to AEs
Up to 7 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GT1 ParticipantsEXPERIMENTALParticipants take MK-7680 capsules by mouth once daily (QD) for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel.
GT3 ParticipantsEXPERIMENTALParticipants take MK-7680 capsules by mouth QD for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel.
Interventions
NameTypeDescription
MK-7680DRUGMK-7680 10 mg and 100 mg capsules
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Is in good health except for HCV infection * Is male or is a female of non-childbearing potential * Clinical diagnosis of HCV GT1 or GT3 with no evidence of mixed-GT or non-typeable infection Exclusion Criteria: * Has a history of clinically significant and not stably contro...

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Competitive Landscape -Hepatitis C 11 trials