Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00518622

First received: August 17, 2007

Last updated: March 27, 2013

Last verified: March 2013

History of Changes

Results First Received: August 10, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Hepatitis C
Interventions:	Drug: Comparator: MK7009 Drug: Comparator: Placebo

Participant Flow

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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

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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.
Total	Total of all reporting groups

Baseline Measures

	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	Total
Number of Participants [units: participants]	3	6	6	5	6	5	4	5	40
Age [units: years] Mean ± Standard Deviation	47.7 ± 2.5	46.8 ± 4.0	46.3 ± 7.1	49.2 ± 5.6	42.3 ± 9.6	46.4 ± 6.8	41.0 ± 14.4	46.2 ± 5.9	45.7 ± 7.4
Age [units: Years] Median ( Full Range )	48.0 ( 45 to 50 )	47.5 ( 40 to 51 )	47.0 ( 38 to 54 )	48.0 ( 41 to 55 )	41.0 ( 28 to 53 )	50.0 ( 38 to 52 )	45.5 ( 21 to 52 )	46.0 ( 40 to 54 )	48.0 ( 21 to 55 )
Gender [units: participants]
Female	0	0	3	0	1	2	0	1	7
Male	3	6	3	5	5	3	4	4	33
Race/Ethnicity, Customized [units: participants]
Caucasian	0	2	5	1	3	2	0	1	14
African American	2	3	1	3	1	3	3	3	19
Hispanic American	1	1	0	1	2	0	1	1	7
Genotype [units: Participants]
Genotype 1	1	1	0	1	0	1	0	0	4
Genotype 1a	1	5	5	4	5	2	4	4	30
Genotype 1b	1	0	1	0	1	2	0	1	6
Plasma HCV RNA [units: Log10 IU/mL] Mean ± Standard Deviation	7.0 ± 0.4	6.7 ± 0.2	6.8 ± 0.4	6.6 ± 0.4	6.7 ± 0.4	6.6 ± 0.5	7.1 ± 0.5	6.3 ± 0.9	6.7 ± 0.5
Plasma HCV RNA [units: Log10 IU/mL] Median ( Full Range )	7.0 ( 6.6 to 7.4 )	6.7 ( 6.4 to 7.1 )	6.8 ( 6.3 to 7.3 )	6.7 ( 6.1 to 7.2 )	6.7 ( 6.2 to 7.4 )	6.6 ( 5.9 to 7.1 )	6.9 ( 6.6 to 7.8 )	6.6 ( 4.8 to 6.9 )	6.7 ( 4.8 to 7.8 )

Outcome Measures

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1. Primary:

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

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2. Primary:

Antiviral Activity of MK7009 [ Time Frame: Baseline and Day 8 ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

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.

Serious Adverse Events

	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
Total, serious adverse events
# participants affected / at risk	0/3 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/6 (0.00%)	0/5 (0.00%)	0/4 (0.00%)	0/5 (0.00%)

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
No text entered.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

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:	March 27, 2013
Health Authority:	United States: Food and Drug Administration

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