Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00518622

Purpose

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

Condition	Intervention	Phase
Hepatitis C	Drug: Comparator: MK7009 Drug: Comparator: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and Tolerability of MK7009 [ Time Frame: 14 days after completion of study therapy ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8

Enrollment:	40
Study Start Date:	July 2007
Study Completion Date:	May 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: MK7009
Experimental: 8 Placebo	Drug: Comparator: Placebo MK7009 Placebo

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518622

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00518622 History of Changes
Other Study ID Numbers:	2007_517, MK7009-004
Study First Received:	August 17, 2007
Results First Received:	August 10, 2009
Last Updated:	April 20, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human

Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on February 09, 2012