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MK-2748

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jan 22, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

MK-2748 · 1 trial · 1 indication

Phase 1 1
NCT01593735A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)Hepatitis C
COMPLETED30 Analytics
PHASE1COMPLETED
A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants
Predose on Day 1 through Day 56
Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT3 HCV-infected participants
Predose on Day 1 through Day 56
Number of participants experiencing clinical or laboratory adverse events (AEs)
From first dose up to 21 days
Number of participants discontinued from study treatment due to AEs
From Day 1 through Day 7

Secondary Endpoints

Area under the plasma concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-2748
Day 1 and Day 7, predose through 24 hours post-dose
Plasma concentration of MK-2748 (C24) on Day 7 of dosing
24 hours post-dose on Day 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Panel A: GT1, low doseEXPERIMENTALParticipants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days.
Panel B: GT1, lower doseEXPERIMENTALParticipants with GT1 HCV will receive lower dose MK-2748 daily for 7 days.
Panel C: GT1, dose based on Panels A+BEXPERIMENTALParticipants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose).
Panel G: GT1, dose based on Panels A+B+CEXPERIMENTALParticipants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C.
Panel H: GT1, dose based on Panels A+B+C+GEXPERIMENTALParticipants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G.
Panel D: GT3, low dose (Omitted)EXPERIMENTALParticipants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel.
Panel E: GT3, high doseEXPERIMENTALParticipants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days.
Panel F: GT3, dose based on Panel EEXPERIMENTALParticipants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose).
Panel I: GT3, dose based on Panels E+FEXPERIMENTALParticipants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F.
Panel J: GT3, dose based on Panels E+F+IEXPERIMENTALParticipants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I.

Interventions

NameTypeDescription
MK-2748DRUGMK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment
PlaceboDRUGPlacebo tablets, orally, once daily 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 infection (GT1 or GT3) for at least 6 months and detectable HCV-RNA in peripheral blood * Body mass index (BMI) of 18 to 37 kg/m\^2 * No clinically significant abnormality on electrocardiogram (ECG) * Stable health * Willing to use appropriate...

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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about MK-2748

What is MK-2748 used for?

MK-2748 is an investigational small molecule being developed for the treatment of Hepatitis C. It is currently in Phase 1 clinical development and has been studied in a completed clinical trial involving participants with Hepatitis C.

Who makes MK-2748?

MK-2748 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for Hepatitis C.

What phase is MK-2748 in?

MK-2748 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 for the drug has been completed.

What clinical trials is MK-2748 in?

MK-2748 has been studied in one completed Phase 1 clinical trial, identified as NCT01593735. This trial was a multiple-dose study evaluating the safety and efficacy of MK-2748 in Hepatitis C-infected participants, with a total enrollment of 30 participants.

Is MK-2748 the same as any other drug?

MK-2748 is the primary name for this investigational drug. No alternative names have been established for this compound in its clinical development program.