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MK-7680

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jul 27, 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

MK-7680 · 1 trial · 1 indication

Phase 1 1
NCT02269059Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)Hepatitis C
COMPLETED13 Analytics
PHASE1COMPLETED
Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in HCV viral load
Day 1: predose, 2, 4, 8, 12, and 24 hours postdose; Days 3, 4, 5, and 6: predose; and Day 7: predose, 4, 12, 24, and 48 hours postdose
Number of participants experiencing an adverse event (AE)
Up to 21 days
Number of participants discontinuing from study therapy due to AEs
Up to 7 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GT1 ParticipantsEXPERIMENTALParticipants take MK-7680 capsules by mouth once daily (QD) for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel.
GT3 ParticipantsEXPERIMENTALParticipants take MK-7680 capsules by mouth QD for 7 days. The starting dose will be 200 mg and the dose will be adjusted in successive panels of participants based on analysis of results of the previous panel.

Interventions

NameTypeDescription
MK-7680DRUGMK-7680 10 mg and 100 mg capsules
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Is in good health except for HCV infection * Is male or is a female of non-childbearing potential * Clinical diagnosis of HCV GT1 or GT3 with no evidence of mixed-GT or non-typeable infection Exclusion Criteria: * Has a history of clinically significant and not stably contro...

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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about MK-7680

What is MK-7680 used for?

MK-7680 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 pharmacokinetics.

Who makes MK-7680?

MK-7680 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in participants with Hepatitis C.

What phase is MK-7680 in?

MK-7680 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in a completed Phase 1 trial to assess its safety and pharmacokinetics in participants with Hepatitis C.

What clinical trials is MK-7680 in?

MK-7680 has been studied in one completed Phase 1 clinical trial, identified as NCT02269059. This trial, titled 'Safety and Pharmacokinetics of MK-7680 in Participants With Hepatitis C (MK-7680-003)', enrolled 13 participants with Hepatitis C.

Is MK-7680 FDA approved?

MK-7680 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Hepatitis C. The drug has completed a Phase 1 trial, but it has not yet received regulatory approval.