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

Merck Sharp & Dohme LLC40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hepatitis C

Interventions

Comparator: MK7009DRUG

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.

Comparator: PlaceboDRUG

MK7009 Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Baseline and Day 8

Data from ClinicalTrials.gov

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