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MK-8876

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Oct 25, 2018

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01930058Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)PHASE1 COMPLETED 9Oct 2, 2013May 5, 2014Oct 25, 2018 -
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Study Endpoints
Primary Endpoints
Mean Change From Baseline in HCV Viral Load
Baseline and Day 7

The mean change (log10) in HCV ribonucleic acid (RNA) from baseline to Day 7 was determined for each panel of participants.

Secondary Endpoints
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (hr) Post-dose (AUC0-24 hr) of MK-8876
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7
Maximum Plasma Concentration (Cmax) of MK-8876
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7
Trough Plasma Concentration (C24hr) of MK-8876
24 hours post-dose on Days 1 and 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Panel A: HCV GT3 MK-8876 150 mgEXPERIMENTALParticipants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.
Panel B: HCV GT3 MK-8876 800 mgEXPERIMENTALParticipants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
Panel E: HCV GT1a MK-8876 800 mgEXPERIMENTALParticipants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
Interventions
NameTypeDescription
MK-8876DRUGMK-8876 10 mg or 100 mg tablets taken q.d. by mouth.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * is male, or female of non-childbearing potential (non-childbearing potential is defined as postmenopausal without menses for ≥1 year or after medically documented hysterectomy, oophorectomy, or tubal ligation) * agrees to use a medically acceptable method of contraception thro...

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Competitive Landscape -Hepatitis C 11 trials