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MK-8876

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Oct 25, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

MK-8876 · 1 trial · 1 indication

Phase 1 1
NCT01930058Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)Hepatitis C
COMPLETED9 Analytics
PHASE1COMPLETED
Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change From Baseline in HCV Viral Load
Baseline and Day 7

The mean change (log10) in HCV ribonucleic acid (RNA) from baseline to Day 7 was determined for each panel of participants.

Secondary Endpoints

Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (hr) Post-dose (AUC0-24 hr) of MK-8876
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7
Maximum Plasma Concentration (Cmax) of MK-8876
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7
Trough Plasma Concentration (C24hr) of MK-8876
24 hours post-dose on Days 1 and 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Panel A: HCV GT3 MK-8876 150 mgEXPERIMENTALParticipants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.
Panel B: HCV GT3 MK-8876 800 mgEXPERIMENTALParticipants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
Panel E: HCV GT1a MK-8876 800 mgEXPERIMENTALParticipants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.

Interventions

NameTypeDescription
MK-8876DRUGMK-8876 10 mg or 100 mg tablets taken q.d. by mouth.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * is male, or female of non-childbearing potential (non-childbearing potential is defined as postmenopausal without menses for ≥1 year or after medically documented hysterectomy, oophorectomy, or tubal ligation) * agrees to use a medically acceptable method of contraception thro...

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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about MK-8876

What is MK-8876 used for?

MK-8876 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 infection.

Who makes MK-8876?

MK-8876 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical research to evaluate the safety, pharmacokinetics, and pharmacodynamics of this investigational drug in Hepatitis C.

What phase is MK-8876 in?

MK-8876 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, which enrolled 9 participants with Hepatitis C.

What clinical trials is MK-8876 in?

MK-8876 has been studied in one completed clinical trial, NCT01930058, titled "Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)." This Phase 1 trial enrolled 9 participants and was controlled but not double-blinded.

Is MK-8876 FDA approved?

MK-8876 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Hepatitis C. The completed trial, NCT01930058, was a controlled Phase 1 study, but the drug has not yet received regulatory approval.