Back to resultsStudy the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: MK7009
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
7
8
Arm Description
25 mg b.i.d. MK7009
75 mg b.i.d. MK7009
250 mg b.i.d. MK7009
500 mg b.i.d. MK7009
700 mg b.i.d. MK7009
125 mg q.d. MK7009
600 mg q.d. MK7009
Placebo
Outcomes
Primary Outcome Measures
Safety and Tolerability of MK7009
Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
Antiviral Activity of MK7009
Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
Secondary Outcome Measures
Full Information
NCT ID
NCT00518622
First Posted
August 17, 2007
Last Updated
August 11, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00518622
Brief Title
Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)
Official Title
A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
25 mg b.i.d. MK7009
Arm Title
2
Arm Type
Experimental
Arm Description
75 mg b.i.d. MK7009
Arm Title
3
Arm Type
Experimental
Arm Description
250 mg b.i.d. MK7009
Arm Title
4
Arm Type
Experimental
Arm Description
500 mg b.i.d. MK7009
Arm Title
5
Arm Type
Experimental
Arm Description
700 mg b.i.d. MK7009
Arm Title
6
Arm Type
Experimental
Arm Description
125 mg q.d. MK7009
Arm Title
7
Arm Type
Experimental
Arm Description
600 mg q.d. MK7009
Arm Title
8
Arm Type
Experimental
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Comparator: MK7009
Other Intervention Name(s)
MK7009
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
MK7009 Placebo
Primary Outcome Measure Information:
Title
Safety and Tolerability of MK7009
Description
Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
Time Frame
14 days after completion of study therapy
Title
Antiviral Activity of MK7009
Description
Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
Time Frame
Baseline and Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23747481
Citation
Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
Results Reference
result
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Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)
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