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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
| 1. Primary: | Safety and Tolerability of MK7009 [ 14 days after completion of study therapy ] |
Hide Outcome Measure 1| 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 |
| 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. |
| 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 | |
|---|---|---|---|---|---|---|---|---|
|
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 |
| 2. Primary: | Antiviral Activity of MK7009 [ Baseline and Day 8 ] |
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 |
