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MK-1075

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jan 22, 2019

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02392494Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)PHASE1 COMPLETED 9Apr 28, 2015Aug 10, 2015Jan 22, 2019 -
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Study Endpoints
Primary Endpoints
Percentage of Participants Experiencing an Adverse Event (AE)
Up to Study Day 14

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that experienced an AE was reported for each treatment panel.

Percentage of Participants Who Discontinued Study Due to an AE
Up to Study Day 14

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that discontinued the study due to an AE was reported for each treatment panel.

Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075
Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose

For assessment of antiviral activity of MK-1075 at each study dose, baseline and post-dose HCV ribonucleic acid (RNA) (log10) were measured at pre-dose and 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. The estimated change from baseline in HCV RNA VL (log10) was calculated for each participant by time point after each single dose, and the maximum change (reduction) in HCV RNA was determined and reported for each treatment arm using an Analysis of Variance (ANOVA) model.

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-1075 100 mg (Panel A)EXPERIMENTALHCV-infected participants receive a single 100 mg dose of MK-1075.
MK-1075 200 mg (Panel B)EXPERIMENTALHCV-infected participants receive a single 200 mg dose of MK-1075.
MK-1075 400 mg (Panel C)EXPERIMENTALHCV-infected participants receive a single 400 mg dose of MK-1075.
MK-1075 800 mg (Panel D)EXPERIMENTALHCV-infected participants receive a single 800 mg dose of MK-1075.
Interventions
NameTypeDescription
MK-1075DRUGMK-1075 supplied as 10 mg or 100 mg tablets for oral administration.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male or female of non-child bearing potential * In good health other than HCV genotype (GT) 1 infection Exclusion Criteria: * Is mentally incapacitated or legally institutionalized * Has a history of clinically significant and not stably controlled endocrine, gastrointestina...

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Competitive Landscape -Hepatitis C 11 trials