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

Sponsored by:	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 male 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

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and Efficacy of the studied doses [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anti-viral activities of studies doses [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Enrollment:	145
Study Start Date:	May 2007
Study Completion Date:	May 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stage 1: Experimental A 50 mg b.i.d. B 75 mg b.i.d. C 150 mg b.i.d. D 250 mg b.i.d. E 125 mg q.d F 500 mg b.i.d. G 600 mg q.d H Placebo	Drug: Comparator: MK7009 Depending on group assignment, patients will receive once daily dosing for 8 days or twice daily dosing for 7 days plus one additional dose on Day 8. Drug: Comparator: Placebo MK7009 Pbo
Stage 2: Experimental I 25 mg b.i.d. J 75 mg b.i.d. K 150 mg b.i.d L 300 mg b.i.d. M 400 mg b.i.d. N 500 mg b.i.d. O 150 mg q.d P 300 mg q.d Q 500 mg q.d R 600 mg q.d S 1000 mg q.d T Placebo	Drug: Comparator: MK7009 Depending on group assignment, patients will receive once daily dosing for 8 days or twice daily dosing for 7 days plus one additional dose on Day 8. Drug: Comparator: Placebo MK7009 Pbo

Eligibility

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:

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
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00518622 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases

Digestive System Diseases
Hepatitis, Viral, Human
Hepatitis C

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 July 02, 2009