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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 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 ]
Antiviral Activity of MK7009 [ Time Frame: Baseline and Day 8 ] [ Designated as safety issue: No ]

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
1: Experimental 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.
2: Experimental 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.
3: Experimental 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.
4: Experimental 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.
5: Experimental 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.
6: Experimental 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.
7: Experimental 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.
8: Experimental 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_517, MK7009-004
Study First Received:	August 17, 2007
Results First Received:	August 10, 2009
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00518622 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases

Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Hepatitis C

ClinicalTrials.gov processed this record on November 27, 2009