Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)

August 11, 2015 updated by: Merck Sharp & Dohme LLC

A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients

The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is a man or a woman aged 18 to 55 years of age.
  • Subject has chronic Hepatitis C
  • Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Exclusion Criteria:

  • Patient has evidence of advanced liver disease.
  • Patient has human immunodeficiency virus (HIV)
  • Patient has Hepatitis B

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
25 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Names:
  • MK7009
Experimental: 2
75 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Names:
  • MK7009
Experimental: 3
250 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Names:
  • MK7009
Experimental: 4
500 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Names:
  • MK7009
Experimental: 5
700 mg b.i.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Names:
  • MK7009
Experimental: 6
125 mg q.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Names:
  • MK7009
Experimental: 7
600 mg q.d. MK7009
Drug: Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Other Names:
  • MK7009
Experimental: 8
Placebo
Drug: Comparator: Placebo
MK7009 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of MK7009
Time Frame: 14 days after completion of study therapy
Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
14 days after completion of study therapy
Antiviral Activity of MK7009
Time Frame: Baseline and Day 8
Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
Baseline and Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 17, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7009-004
  • 2007_517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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