Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Condition:	Hepatitis C
Interventions:	Drug: Comparator: MK7009 Drug: Comparator: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 11 sites in the US and 1 site in Germany. Date of first patient visit: 6-Jul-2007; Date of last patient visit: 5-Sep-2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
To be eligible for enrollment into this study, all patients must have met a number of laboratory criteria including, but not limited to, the presence of hepatitis C virus (HCV) ribonucleic acid (RNA) and HCV genotyping.

Reporting Groups

	Description
25 mg b.i.d. MK7009	Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
75 mg b.i.d. MK7009	Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
250 mg b.i.d. MK7009	Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
500 mg b.i.d. MK7009	Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
700 mg b.i.d. MK7009	Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
125 mg q.d. MK7009	Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days. Patients received 125 mg of MK7009 on the morning of Day 8.
600 mg q.d. MK7009	Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
Placebo	Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.

Participant Flow: Overall Study

	25 mg b.i.d. MK7009	75 mg b.i.d. MK7009	250 mg b.i.d. MK7009	500 mg b.i.d. MK7009	700 mg b.i.d. MK7009	125 mg q.d. MK7009	600 mg q.d. MK7009	Placebo
STARTED	3	6	6	5	6	5	4	5
Completed Therapy	3^[1]	5	6	5	6	5	4	5
Discontinued Therapy	0^[2]	1	0	0	0	0	0	0
COMPLETED	3	5	5	5	6	5	4	5
NOT COMPLETED	0	1	1	0	0	0	0	0
Lost to Follow-up	0	0	1	0	0	0	0	0
Study medication taken incorrectly	0	1	0	0	0	0	0	0

[1]	Completed therapy defined if participant has taken 8 days of study medication per the protocol.
[2]	Discontinued therapy defined if participant has not taken 8 days of medication per the protocol.

Baseline Characteristics

Outcome Measures

1. Primary:

Safety and Tolerability of MK7009 [ 14 days after completion of study therapy ]

Show Outcome Measure 1

2. Primary:

Antiviral Activity of MK7009 [ Baseline and Day 8 ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372

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