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MK-2248

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jun 8, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02161510Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)PHASE1 COMPLETED 13Jul 1, 2014Apr 1, 2015Jun 8, 2015 -
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Study Endpoints
Primary Endpoints
Maximum change from baseline in VL
Up to Day 42
Number of participants experiencing an adverse event (AE)
Up to Day 42
Number of participants who discontinue from study treatment due to an AE
Up to Day 7
Secondary Endpoints
Plasma concentration at 24 hours post-dose (C24hr) of MK-2248 and circulating metabolite(s)
Up to Day 10
Area under the plasma-concentration curve at zero to 24 hours post-dose (AUC[0-24hr]) of MK-2248 and circulating metabolite(s)
Up to Day 10
Maximum observed post-dose plasma concentration (Cmax) of MK-2248 and circulating metabolite(s)
Up to Day 10
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part I: MK-2248 200 mg (Panel A)EXPERIMENTALHCV participants will take MK-2248 200 mg by mouth once daily for 7 days.
Part I: MK-2248 ≤800 mg (Panel B)EXPERIMENTALBased on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Part I: MK-2248 ≤800 mg (Panel C)EXPERIMENTALBased on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth for 7 days.
Part I: MK-2248 ≤800 mg (Panel D)EXPERIMENTALBased on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Part II: MK-2248 200 mg (Panel E)EXPERIMENTALHCV participants will take MK-2248 200 mg by mouth once daily for 7 days.
Part II: MK-2248 ≤800 mg (Panel F)EXPERIMENTALBased on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Part II: MK-2248 ≤800 mg (Panel G)EXPERIMENTALBased on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Part II: MK-2248 ≤800 mg (Panel H)EXPERIMENTALBased on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Part III: MK-2248 ≤800 mg (Panel I)EXPERIMENTALBased on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Part III: MK-2248 ≤800 mg (Panel J)EXPERIMENTALBased on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Interventions
NameTypeDescription
MK-2248DRUGMK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * clinical diagnosis of chronic HCV defined by positive serology for HCV or positive HCV RNA for at least 6 months and detectable HCV RNA in peripheral blood ≥10\^5 IU/mL at screening * Body Mass Index (BMI) ≥18 to \<37 kg/m\^2 * in good health other than HCV infection with norm...

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Competitive Landscape -Hepatitis C 11 trials