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| 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
| 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. |
| 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. |
| 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. |
| 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
| 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. |
| 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
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
| 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. |
| 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 |
