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

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

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Comparator: MK7009
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>25 mg b.i.d. MK7009 | Drug: Comparator: MK7009<br>* 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.<br>* Other names: MK7009;|
| Experimental: 2<br>75 mg b.i.d. MK7009 | Drug: Comparator: MK7009<br>* 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.<br>* Other names: MK7009;|
| Experimental: 3<br>250 mg b.i.d. MK7009 | Drug: Comparator: MK7009<br>* 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.<br>* Other names: MK7009;|
| Experimental: 4<br>500 mg b.i.d. MK7009 | Drug: Comparator: MK7009<br>* 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.<br>* Other names: MK7009;|
| Experimental: 5<br>700 mg b.i.d. MK7009 | Drug: Comparator: MK7009<br>* 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.<br>* Other names: MK7009;|
| Experimental: 6<br>125 mg q.d. MK7009 | Drug: Comparator: MK7009<br>* 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.<br>* Other names: MK7009;|
| Experimental: 7<br>600 mg q.d. MK7009 | Drug: Comparator: MK7009<br>* 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.<br>* Other names: MK7009;|
| Experimental: 8<br>Placebo | Drug: Comparator: Placebo<br>* MK7009 Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 days after completion of study therapy | 
| Antiviral Activity of MK7009 | Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8 | Baseline and Day 8 |