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

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

Completed

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: MK7009

Drug

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

Comparator: placebo

Drug

MK7009 Placebo

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Aug 21, 2007
Registry last updated: Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed