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

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: MK7009 Drug: Comparator: Placebo (unspecified)	Phase I

MedlinePlus related topics:

Hepatitis Hepatitis C

U.S. FDA Resources

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

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: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	145
Study Start Date:	August 2007
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stage 1 Stage 1: 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: 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. Stage 1: 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 Stage 2: 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: Placebo (unspecified) MK7009 Pbo.
Stage 2 Stage 2: 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: 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. Stage 1: 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 Stage 2: 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: Placebo (unspecified) 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

Contacts


Contact: Toll Free Number	1-888-577-8839

Locations


United States, Louisiana
	Call for Information	Recruiting
	Baton Rouge, Louisiana, United States, 70808

United States, Maryland
	Call for Information	Recruiting
	Baltimore, Maryland, United States, 21287
	Call for Information	Recruiting
	Baltimore, Maryland, United States, 21201

United States, Michigan
	Call for Information	Recruiting
	Detroit, Michigan, United States, 48202-0000

United States, New Jersey
	Call for Information	Recruiting
	Newark, New Jersey, United States, 17101-1709

United States, New York
	Call for Information	Recruiting
	Rochester, New York, United States, 14534
	Call for Information	Recruiting
	New York, New York, United States, 10029
	Call for Information	Recruiting
	New York, New York, United States, 10021
	Call for Information	Recruiting
	Manhasset, New York, United States, 11030-0000

United States, Pennsylvania
	Call for Information	Recruiting
	Philadelphia, Pennsylvania, United States, 19107-5244

United States, Texas
	Call for Information	Recruiting
	San Antonio, Texas, United States, 78215
	Call for Information	Recruiting
	Dallas, Texas, United States, 75208

United States, Virginia
	Call for Information	Recruiting
	Fairfax, Virginia, United States, 22031

Belgium
	Merck Sharp & Dohme B.V.	Recruiting
	Bruxelles, Belgium, 1180
	Contact: Nathalie Schrameijer 32-2-373-4310

Germany
	Msd Sharp & Dohme Gmbh	Recruiting
	Haar, Germany, 85540
	Contact: Thomas Lang 49-89-4561-1536

Taiwan
	Merck Sharp & Dohme (I.A.) Corp.	Recruiting
	Taipei, Taiwan, [106
	Contact: David Chung 886-2-23761670

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_517, MK7009-004
First Received:	August 17, 2007
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00518622
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:

RNA Virus Infections

Flaviviridae Infections

ClinicalTrials.gov processed this record on September 05, 2008

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