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MK-1075

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jan 22, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

MK-1075 · 2 trials · 2 indications

Phase 1 2
NCT02461563A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)Hepatitis C Virus Infection
COMPLETED12 Analytics
NCT02392494Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)Hepatitis C
COMPLETED9 Analytics
PHASE1COMPLETED
A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)
Hepatitis C Virus InfectionUnlock trial analytics
PHASE1COMPLETED
Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Experienced an Adverse Event (AE)
Up to Day 42

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Number of Participants Who Discontinued Treatment Due to an AE
Up to Day 7

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Change From Baseline in Maximum log10 HCV RNA Following Multiple Dose Oral Administration of MK-1075
Day 1 (pre-dose, 2, 4, 8, 12, and 24 hours postdose); Days 3, 4, 5, 6 (pre-dose); Day 7 (predose, 4, 12, 24, 48, 72, 96, 120, and 192 hours postdose); Days 21, 28 and 42

Blood was collected on Days 1, 3, 4, 5, 6, 7, 21, 28 and 42, where baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. Change from baseline in log10 HCV RNA levels, was determined, and the maximum reduction in HCV RNA was analyzed by an ANOVA model with a fixed effect for treatment. The primary hypothesis is, with a posterior probability larger than 70%, there is at least a 3 log10 reduction from baseline in HCV RNA.

Percentage of Participants Experiencing an Adverse Event (AE)
Up to Study Day 14

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that experienced an AE was reported for each treatment panel.

Percentage of Participants Who Discontinued Study Due to an AE
Up to Study Day 14

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that discontinued the study due to an AE was reported for each treatment panel.

Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075
Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose

For assessment of antiviral activity of MK-1075 at each study dose, baseline and post-dose HCV ribonucleic acid (RNA) (log10) were measured at pre-dose and 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. The estimated change from baseline in HCV RNA VL (log10) was calculated for each participant by time point after each single dose, and the maximum change (reduction) in HCV RNA was determined and reported for each treatment arm using an Analysis of Variance (ANOVA) model.

Secondary Endpoints

Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of MK-1075 Following Multiple Dose Oral Administration of MK-1075
Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
AUC 0-24hr of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075
Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose
Area Under the Plasma Concentration Time Curve From Time 0 to Last (AUC 0-last) of MK-1075 Following Multiple Dose Oral Administration of MK-1075
Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GT1: 200 mg MK-1075EXPERIMENTALFasted GT1 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT1: 400 mg MK-1075EXPERIMENTALFasted GT1 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT1: 800 mg MK-1075EXPERIMENTALFasted GT1 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT3: 200 mg MK-1075EXPERIMENTALFasted GT3 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT3: 400 mg MK-1075EXPERIMENTALFasted GT3 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT3: 800 mg MK-1075EXPERIMENTALFasted GT3 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
MK-1075 100 mg (Panel A)EXPERIMENTALHCV-infected participants receive a single 100 mg dose of MK-1075.
MK-1075 200 mg (Panel B)EXPERIMENTALHCV-infected participants receive a single 200 mg dose of MK-1075.
MK-1075 400 mg (Panel C)EXPERIMENTALHCV-infected participants receive a single 400 mg dose of MK-1075.
MK-1075 800 mg (Panel D)EXPERIMENTALHCV-infected participants receive a single 800 mg dose of MK-1075.

Interventions

NameTypeDescription
200 mg MK-1075DRUGTwo 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
400 mg MK-1075DRUGFour 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
800 mg MK-1075DRUGEight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
MK-1075DRUGMK-1075 supplied as 10 mg or 100 mg tablets for oral administration.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Female of non-childbearing potential * Have a body mass index (BMI) \>=18 to =\< 37 kg/m\^2 * Excepting HCV infection, be in good health * Have a clinical diagnosis of chronic HCV infection, exclusively GT1 or exclusively GT3 * Agree to follow smoking restrictions Exclusion C...

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Competitive Landscape -Hepatitis C 11 trials

Frequently asked questions about MK-1075

What is MK-1075 used for?

MK-1075 is an investigational small molecule being developed for the treatment of Hepatitis C and Hepatitis C Virus Infection. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes MK-1075?

MK-1075 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Hepatitis C.

What phase is MK-1075 in?

MK-1075 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The completed Phase 1 trials were designed to evaluate the drug in participants with Hepatitis C virus infection.

What clinical trials is MK-1075 in?

MK-1075 has been studied in two completed Phase 1 clinical trials: NCT02392494, which evaluated the drug in participants with Hepatitis C, and NCT02461563, a multiple-dose study in participants with Hepatitis C Virus Infection. Both trials enrolled adult participants.

Is MK-1075 the same as another drug?

MK-1075 is the primary identifier for this investigational compound. No alternative names have been associated with this drug in the available clinical trial information. It is being studied specifically for its potential role in treating Hepatitis C infections.