Hepatitis C
Conditions
Brief summary
The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C
Interventions
DRUGComparator: MK7009
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.
DRUGComparator: Placebo
MK7009 Placebo
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Subject is a man or a woman aged 18 to 55 years of age. * Subject has chronic Hepatitis C * Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period
Exclusion criteria
* Patient has evidence of advanced liver disease. * Patient has human immunodeficiency virus (HIV) * Patient has Hepatitis B
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of MK7009 | 14 days after completion of study therapy | Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication |
| Antiviral Activity of MK7009 | Baseline and Day 8 | Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8 |
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 6 |
| 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. | 6 |
| 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. | 5 |
| 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. | 6 |
| 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. | 5 |
| 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. | 4 |
| 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. | 5 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Study medication taken incorrectly | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 48.0 Years | 47.5 Years | 47.0 Years | 48.0 Years | 41.0 Years | 50.0 Years | 45.5 Years | 46.0 Years | 48.0 Years |
| Genotype Genotype 1 | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Genotype Genotype 1a | 1 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 2 Participants | 4 Participants | 4 Participants | 30 Participants |
| Genotype Genotype 1b | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 6 Participants |
| Plasma HCV RNA | 7.0 Log10 IU/mL | 6.7 Log10 IU/mL | 6.8 Log10 IU/mL | 6.7 Log10 IU/mL | 6.7 Log10 IU/mL | 6.6 Log10 IU/mL | 6.9 Log10 IU/mL | 6.6 Log10 IU/mL | 6.7 Log10 IU/mL STANDARD_DEVIATION 0.5 |
| Race/Ethnicity, Customized African American | 2 participants | 3 participants | 1 participants | 3 participants | 1 participants | 3 participants | 3 participants | 3 participants | 19 participants |
| Race/Ethnicity, Customized Caucasian | 0 participants | 2 participants | 5 participants | 1 participants | 3 participants | 2 participants | 0 participants | 1 participants | 14 participants |
| Race/Ethnicity, Customized Hispanic American | 1 participants | 1 participants | 0 participants | 1 participants | 2 participants | 0 participants | 1 participants | 1 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants | 5 Participants | 5 Participants | 3 Participants | 4 Participants | 4 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 3 | 3 / 6 | 6 / 6 | 4 / 5 | 2 / 6 | 5 / 5 | 1 / 4 | 3 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 4 | 0 / 5 |
Outcome results
Primary
Antiviral Activity of MK7009
Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
Time frame: Baseline and Day 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 25 mg b.i.d. MK7009 | Antiviral Activity of MK7009 | -1.90 Log10 IU/mL HCV RNA | Standard Deviation 0.4 |
| 75 mg b.i.d. MK7009 | Antiviral Activity of MK7009 | -2.54 Log10 IU/mL HCV RNA | Standard Deviation 0.69 |
| 250 mg b.i.d. MK7009 | Antiviral Activity of MK7009 | -2.80 Log10 IU/mL HCV RNA | Standard Deviation 0.96 |
| 500 mg b.i.d. MK7009 | Antiviral Activity of MK7009 | -3.27 Log10 IU/mL HCV RNA | Standard Deviation 0.98 |
| 700 mg b.i.d. MK7009 | Antiviral Activity of MK7009 | -4.62 Log10 IU/mL HCV RNA | Standard Deviation 0.39 |
| 125 mg q.d. MK7009 | Antiviral Activity of MK7009 | -1.82 Log10 IU/mL HCV RNA | Standard Deviation 0.61 |
| 600 mg q.d. MK7009 | Antiviral Activity of MK7009 | -2.35 Log10 IU/mL HCV RNA | Standard Deviation 0.21 |
| Placebo | Antiviral Activity of MK7009 | 0.11 Log10 IU/mL HCV RNA | Standard Deviation 0.18 |
95% CI: [-2.87, -1.14]
95% CI: [-3.49, -1.8]
95% CI: [-3.9, -1.9]
95% CI: [-4.59, -2.17]
95% CI: [-5.15, -4.31]
95% CI: [-2.68, -1.18]
95% CI: [-2.78, -2.13]
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
Time frame: 14 days after completion of study therapy
Population: All treated patients are included in the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 25 mg b.i.d. MK7009 | Safety and Tolerability of MK7009 | 2 Participants |
| 75 mg b.i.d. MK7009 | Safety and Tolerability of MK7009 | 3 Participants |
| 250 mg b.i.d. MK7009 | Safety and Tolerability of MK7009 | 6 Participants |
| 500 mg b.i.d. MK7009 | Safety and Tolerability of MK7009 | 4 Participants |
| 700 mg b.i.d. MK7009 | Safety and Tolerability of MK7009 | 2 Participants |
| 125 mg q.d. MK7009 | Safety and Tolerability of MK7009 | 5 Participants |
| 600 mg q.d. MK7009 | Safety and Tolerability of MK7009 | 1 Participants |
| Placebo | Safety and Tolerability of MK7009 | 3 Participants |