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

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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.

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 [ 14 days after completion of study therapy ]

Measure Type	Primary
Measure Title	Safety and Tolerability of MK7009
Measure Description	Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
Time Frame	14 days after completion of study therapy
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated patients are included in the safety analysis.

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.

Measured Values

	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
Number of Participants Analyzed [units: participants]	3	6	6	5	6	5	4	5
Safety and Tolerability of MK7009 [units: Participants]	2	3	6	4	2	5	1	3

No statistical analysis provided for Safety and Tolerability of MK7009

2. Primary:

Antiviral Activity of MK7009 [ Baseline and Day 8 ]

Measure Type	Primary
Measure Title	Antiviral Activity of MK7009
Measure Description	Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
Time Frame	Baseline and Day 8
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol population (defined as the study participants that completed the study as defined by the protocol). One participant was excluded from the analysis due to incorrect dosing of study medication.

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.

Measured Values

	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
Number of Participants Analyzed [units: participants]	3	5	6	5	6	5	4	5
Antiviral Activity of MK7009 [units: Log10 IU/mL HCV RNA] Mean ± Standard Deviation	-1.90 ± 0.40	-2.54 ± 0.69	-2.80 ± 0.96	-3.27 ± 0.98	-4.62 ± 0.39	-1.82 ± 0.61	-2.35 ± 0.21	0.11 ± 0.18

Statistical Analysis 1 for Antiviral Activity of MK7009

Groups ^[1]	25 mg b.i.d. MK7009 vs. Placebo
Mean Difference (Net) ^[2]	-2.01
95% Confidence Interval	( -2.87 to -1.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Mean (Day 8 – baseline) HCV RNA for MK7009 25 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo

Statistical Analysis 2 for Antiviral Activity of MK7009

Groups ^[1]	75 mg b.i.d. MK7009 vs. Placebo
Mean Difference (Net) ^[2]	-2.64
95% Confidence Interval	( -3.49 to -1.80 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Mean (Day 8 – baseline) HCV RNA for MK7009 75 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo

Statistical Analysis 3 for Antiviral Activity of MK7009

Groups ^[1]	250 mg b.i.d. MK7009 vs. Placebo
Mean Difference (Net) ^[2]	-2.90
95% Confidence Interval	( -3.90 to -1.90 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Mean (Day 8 – baseline) HCV RNA for MK7009 250 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo

Statistical Analysis 4 for Antiviral Activity of MK7009

Groups ^[1]	500 mg b.i.d. MK7009 vs. Placebo
Mean Difference (Net) ^[2]	-3.38
95% Confidence Interval	( -4.59 to -2.17 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Mean (Day 8 – baseline) HCV RNA for MK7009 500 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo

Statistical Analysis 5 for Antiviral Activity of MK7009

Groups ^[1]	700 mg b.i.d. MK7009
Mean Difference (Net) ^[2]	-4.73
95% Confidence Interval	( -5.15 to -4.31 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Mean (Day 8 – baseline) HCV RNA for MK7009 700 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo

Statistical Analysis 6 for Antiviral Activity of MK7009

Groups ^[1]	125 mg q.d. MK7009 vs. Placebo
Mean Difference (Net) ^[2]	-1.93
95% Confidence Interval	( -2.68 to -1.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Mean (Day 8 – baseline) HCV RNA for MK7009 125 mg qd minus mean (Day 8 – baseline) HCV RNA for placebo

Statistical Analysis 7 for Antiviral Activity of MK7009

Groups ^[1]	600 mg q.d. MK7009 vs. Placebo
Mean Difference (Net) ^[2]	-2.46
95% Confidence Interval	( -2.78 to -2.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Mean (Day 8 – baseline) HCV RNA for MK7009 600 mg qd minus mean (Day 8 – baseline) HCV RNA for placebo

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