Hepatitis C Virus InfectionPhase 1NCT02461563

A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)

A Phase 1 study testing 200 mg MK-1075, 400 mg MK-1075 and 800 mg MK-1075 in people with Hepatitis C Virus Infection, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis C Virus Infection
What is being tested?: 200 mg MK-1075, 400 mg MK-1075 and 800 mg MK-1075
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: 23 Jun 2015to 23 Dec 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Has a history of clinically significant, not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
Have been treated with amiodarone within the prior year, or is currently on beta-blockers or verapamil
Has a history of cancer (malignancy)
Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV)
Has had major surgery, donated or lost approximately 500 mL blood within 4 weeks prior to screening visit

Show all 13Show fewer

Has participated in another drug trial within 4 weeks prior to screening visit
Is taking a non-permitted medication to treat a co-morbid condition
Consumes greater than 2 glasses of alcoholic beverages
Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months
Has evidence or history of chronic hepatitis not caused by HCV, including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis
Has been treated with other HCV inhibitors, such as sofosbuvir or VX-135
Has evidence of advanced or decompensated liver disease, bridging fibrosis or higher grade fibrosis from a prior liver biopsy

About this study

Official title: A Multiple-Dose Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of MK-1075 in GT3 and GT1 HCV Infected Patients

This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.

Conditions: Hepatitis C Virus Infection
Being tested: 200 mg MK-1075, 400 mg MK-1075, 800 mg MK-1075
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

200 mg MK-1075Drug
Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
400 mg MK-1075Drug
Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
800 mg MK-1075Drug
Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

Study groups in NCT02461563
Study group	Role	What they receive
GT1: 200 mg MK-1075	Experimental	Fasted GT1 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days Receives: Drug: 200 mg MK-1075
GT1: 400 mg MK-1075	Experimental	Fasted GT1 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days Receives: Drug: 400 mg MK-1075
GT1: 800 mg MK-1075	Experimental	Fasted GT1 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days Receives: Drug: 800 mg MK-1075
GT3: 200 mg MK-1075	Experimental	Fasted GT3 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days Receives: Drug: 200 mg MK-1075
GT3: 400 mg MK-1075	Experimental	Fasted GT3 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days Receives: Drug: 400 mg MK-1075
GT3: 800 mg MK-1075	Experimental	Fasted GT3 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days Receives: Drug: 800 mg MK-1075

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced an Adverse Event (AE)
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.
Measured: Up to Day 42
Number of Participants Who Discontinued Treatment Due to an AE
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.
Measured: Up to Day 7
Change From Baseline in Maximum log10 HCV RNA Following Multiple Dose Oral Administration of MK-1075
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.
Measured: 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

Secondary outcomes (6)

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
Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC 0-24hr of MK-1075 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on MK-1075 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.
Measured: 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
Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC 0-24hr of the MK-1075 metabolite M1 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on M1 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.
Measured: 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
Blood was collected from pre-dose up to 120 hours post-dose in order to determine the plasma AUC 0-last of MK-1075 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on MK-1075 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.
Measured: 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
AUC 0-last of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075
Blood was collected from pre-dose up to 120 hours post-dose in order to determine the plasma AUC 0-last of M1 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on M1 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.
Measured: 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
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-1075 Following Multiple Dose Oral Administration of MK-1075
Blood was collected at 24 hours post-dose in order to determine the plasma C24hr of MK- 1075 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on MK-1075 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3).
Measured: Day 7 at 24 hours postdose
C24hr of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075
Blood was collected at 24 hours post-dose in order to determine the plasma C24hr of MK-1075 metabolite M1 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on M1 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3).
Measured: Day 7 at 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 201523 Dec 2015

First posted3 Jun 2015 (estimated)
Study start23 Jun 2015
Primary completion23 Dec 2015
Study completion23 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02461563
Sponsor's protocol ID: 1075-004
Other IDs: 2015-001687-18, 2015
Status last verified: Apr 2018
First submitted: 1 Jun 2015
Last updated: 13 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

All Hepatitis C Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple-Dose Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of MK-1075 in GT3 and GT1 HCV Infected Patients
ClinicalTrials.gov ID: NCT02461563
Acronym / sponsor ID: 1075-004
Conditions: Hepatitis C Virus Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 23 Jun 2015 (actual)
Primary completion: 23 Dec 2015 (actual)
Study completion: 23 Dec 2015 (actual)
First posted: 3 Jun 2015 (estimated)
Results: Posted 13 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
GT1: 200 mg MK-1075	Experimental	Drug: 200 mg MK-1075Fasted GT1 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT1: 400 mg MK-1075	Experimental	Drug: 400 mg MK-1075Fasted GT1 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT1: 800 mg MK-1075	Experimental	Drug: 800 mg MK-1075Fasted GT1 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT3: 200 mg MK-1075	Experimental	Drug: 200 mg MK-1075Fasted GT3 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT3: 400 mg MK-1075	Experimental	Drug: 400 mg MK-1075Fasted GT3 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
GT3: 800 mg MK-1075	Experimental	Drug: 800 mg MK-1075Fasted GT3 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (13 listed)

Has a history of clinically significant, not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
Have been treated with amiodarone within the prior year, or is currently on beta-blockers or verapamil
Has a history of cancer (malignancy)
Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
200 mg MK-1075Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days	Drug	GT1: 200 mg MK-1075, GT3: 200 mg MK-1075
400 mg MK-1075Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days	Drug	GT1: 400 mg MK-1075, GT3: 400 mg MK-1075
800 mg MK-1075Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days	Drug	GT1: 800 mg MK-1075, GT3: 800 mg MK-1075

Primary outcome

Number of Participants Who Experienced an Adverse Event (AE)
Time frame: 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
Time frame: 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
Time frame: 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.

6 secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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
AUC 0-last of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075
Time frame: 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
Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-1075 Following Multiple Dose Oral Administration of MK-1075
Time frame: Day 7 at 24 hours postdose
C24hr of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075
Time frame: Day 7 at 24 hours postdose

Results and safety

Results posted to the registry on 13 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GT1 400 mg MK-1075	3	3
GT1 MK-1075 600 mg	3	3
GT3 400 mg MK-1075	3	3
GT3 600 mg MK-1075	3	3

Primary outcome: Number of Participants Who Experienced an Adverse Event (AE)

Time frame: Up to Day 42. Count of participants. Unit: Participants

Measure	GT1 400 mg MK-1075 n = 3	GT1 MK-1075 600 mg n = 3	GT3 400 mg MK-1075 n = 3	GT3 600 mg MK-1075 n = 3
Value	3	2	3	2

Population analysed: Participants who received at least one dose of the investigational drug.

Primary outcome: Number of Participants Who Discontinued Treatment Due to an AE

Time frame: Up to Day 7. Count of participants. Unit: Participants

Measure	GT1 400 mg MK-1075 n = 3	GT1 MK-1075 600 mg n = 3	GT3 400 mg MK-1075 n = 3	GT3 600 mg MK-1075 n = 3
Value	0	0	0	0

Population analysed: Participants who received at least one dose of the investigational drug.

Primary outcome: Change From Baseline in Maximum log10 HCV RNA Following Multiple Dose Oral Administration of MK-1075

Time frame: 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. Least squares mean (90% Confidence Interval). Unit: log10 IU/mL

Measure	GT1 400 mg MK-1075 n = 3	GT1 MK-1075 600 mg n = 3	GT3 400 mg MK-1075 n = 3	GT3 600 mg MK-1075 n = 3
Value	3.465 (2.427 to 4.502)	4.122 (3.084 to 5.159)	4.071 (3.034 to 5.109)	5.132 (4.095 to 6.169)

Population analysed: Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Pre-treatment: 28 days before treatment up to Treatment; Treatment: Day 1 up to Day 7; Post-Treatment: Day 8 up to day 42. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GT1 Pre-treatment	0 of 6 (0%)	0 of 6 (0%)	0 of 6
GT3 Pre-treatment	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
GT1 400 mg MK-1075	0 of 3 (0%)	3 of 3 (100%)	0 of 3
GT1 600 mg MK-1075	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
GT3 MK-1075 400 mg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
GT3 600 mg MK-1075	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
GT1 Post-study	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
GT3 Post-study	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C Virus Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 200 mg MK-1075, 400 mg MK-1075 and 800 mg MK-1075 in people with Hepatitis C Virus Infection, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced an Adverse Event (AE) (time frame: Up to Day 42). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02461563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.