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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_517 |
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The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 25 mg b.i.d. MK7009 |
|
| 2 | Experimental | 75 mg b.i.d. MK7009 |
|
| 3 | Experimental | 250 mg b.i.d. MK7009 |
|
| 4 | Experimental | 500 mg b.i.d. MK7009 |
|
| 5 | Experimental | 700 mg b.i.d. MK7009 |
|
| 6 | Experimental | 125 mg q.d. MK7009 |
|
| 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: MK7009 | Drug | Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of MK7009 | Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication | 14 days after completion of study therapy |
| Antiviral Activity of MK7009 | Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8 | Baseline and Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23747481 | Result | Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability of MK7009 | Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication | All treated patients are included in the safety analysis. | Posted | Number | Participants | 14 days after completion of study therapy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C540393 | vaniprevir |
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600 mg q.d. MK7009 |
|
| 8 | Experimental | Placebo |
|
|
| Comparator: Placebo | Drug | MK7009 Placebo |
|
| Study medication taken incorrectly |
|
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Genotype | Number | Participants |
|
| Plasma HCV RNA | Mean | Standard Deviation | Log10 IU/mL |
|
| Plasma HCV RNA | Median | Full Range | Log10 IU/mL |
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
|
|
| Primary | Antiviral Activity of MK7009 | Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8 | 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. | Posted | Mean | Standard Deviation | Log10 IU/mL HCV RNA | Baseline and Day 8 |
|
|
|
|
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | 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. | 0 | 6 | 3 | 6 |
| EG002 | 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. | 0 | 6 | 6 | 6 |
| EG003 | 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. | 0 | 5 | 4 | 5 |
| EG004 | 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. | 0 | 6 | 2 | 6 |
| EG005 | 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. | 0 | 5 | 5 | 5 |
| EG006 | 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. | 0 | 4 | 1 | 4 |
| EG007 | 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. | 0 | 5 | 3 | 5 |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Axillary Pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Energy Increased | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Vessel Puncture Site Pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Blood Potassium Decreased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Blood Urea Increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Electrocardiogram PQ Interval Prolonged | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Sinus Headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Abnormal Dreams | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
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.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Mean Difference (Net) |
| -2.64 |
| 95 |
| -3.49 |
| -1.80 |
Mean (Day 8 - baseline) HCV RNA for MK7009 75 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo |
| No |
| Superiority or Other |
| Mean Difference (Net) | -2.90 | 95 | -3.90 | -1.90 | Mean (Day 8 - baseline) HCV RNA for MK7009 250 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo | No | Superiority or Other |
| Mean Difference (Net) | -3.38 | 95 | -4.59 | -2.17 | Mean (Day 8 - baseline) HCV RNA for MK7009 500 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo | No | Superiority or Other |
| Mean Difference (Net) | -4.73 | 95 | -5.15 | -4.31 | Mean (Day 8 - baseline) HCV RNA for MK7009 700 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo | No | Superiority or Other |
| Mean Difference (Net) | -1.93 | 95 | -2.68 | -1.18 | Mean (Day 8 - baseline) HCV RNA for MK7009 125 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo | No | Superiority or Other |
| Mean Difference (Net) | -2.46 | 95 | -2.78 | -2.13 | Mean (Day 8 - baseline) HCV RNA for MK7009 600 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo | No | Superiority or Other |