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MK-2248

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jun 8, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

MK-2248 · 1 trial · 1 indication

Phase 1 1
NCT02161510Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)Hepatitis C
COMPLETED13 Analytics
PHASE1COMPLETED
Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)
Hepatitis CUnlock trial analytics

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 to 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

Frequently asked questions about MK-2248

What is MK-2248 used for?

MK-2248 is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and effectiveness.

Who makes MK-2248?

MK-2248 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is in Phase 1 clinical development for Hepatitis C.

What phase is MK-2248 in?

MK-2248 is in Phase 1 clinical development. It is an investigational drug for Hepatitis C and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed to evaluate its safety, pharmacokinetics, and pharmacodynamics.

What clinical trials is MK-2248 in?

MK-2248 has one completed clinical trial, NCT02161510, titled "Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)." This Phase 1 study enrolled 13 participants aged 18 years and older with Hepatitis C.

Is MK-2248 the same as any other drug?

No alternative names for MK-2248 have been reported. The drug is identified by its code name MK-2248 and is being developed by Merck & Company, Inc. for the treatment of Hepatitis C.