Trial Outcomes & Findings for Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED) (NCT NCT00518622)
NCT ID: NCT00518622
Last Updated: 2015-08-25
Results Overview
Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
14 days after completion of study therapy
Results posted on
2015-08-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
6
|
5
|
6
|
5
|
4
|
5
|
|
Overall Study
Completed Therapy
|
3
|
5
|
6
|
5
|
6
|
5
|
4
|
5
|
|
Overall Study
Discontinued Therapy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
5
|
5
|
5
|
6
|
5
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|---|---|---|---|
|
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
Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)
Baseline characteristics by cohort
| Measure |
25 mg b.i.d. MK7009
n=3 Participants
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
n=6 Participants
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
n=6 Participants
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
n=5 Participants
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
n=6 Participants
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
n=5 Participants
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
n=4 Participants
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
n=5 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.0 Years
n=5 Participants
|
47.5 Years
n=7 Participants
|
47.0 Years
n=5 Participants
|
48.0 Years
n=4 Participants
|
41.0 Years
n=21 Participants
|
50.0 Years
n=10 Participants
|
45.5 Years
n=115 Participants
|
46.0 Years
n=6 Participants
|
48.0 Years
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
33 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=6 Participants
|
14 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=10 Participants
|
3 participants
n=115 Participants
|
3 participants
n=6 Participants
|
19 participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
1 participants
n=6 Participants
|
7 participants
n=6 Participants
|
|
Genotype
Genotype 1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Genotype
Genotype 1a
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
30 Participants
n=6 Participants
|
|
Genotype
Genotype 1b
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
|
Plasma HCV RNA
|
7.0 Log10 IU/mL
n=5 Participants
|
6.7 Log10 IU/mL
n=7 Participants
|
6.8 Log10 IU/mL
n=5 Participants
|
6.7 Log10 IU/mL
n=4 Participants
|
6.7 Log10 IU/mL
n=21 Participants
|
6.6 Log10 IU/mL
n=10 Participants
|
6.9 Log10 IU/mL
n=115 Participants
|
6.6 Log10 IU/mL
n=6 Participants
|
6.7 Log10 IU/mL
n=6 Participants
|
PRIMARY outcome
Timeframe: 14 days after completion of study therapyPopulation: All treated patients are included in the safety analysis.
Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication
Outcome measures
| Measure |
25 mg b.i.d. MK7009
n=3 Participants
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
n=6 Participants
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
n=6 Participants
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
n=5 Participants
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
n=6 Participants
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
n=5 Participants
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
n=4 Participants
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
n=5 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of MK7009
|
2 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 8Population: 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.
Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8
Outcome measures
| Measure |
25 mg b.i.d. MK7009
n=3 Participants
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
n=5 Participants
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
n=6 Participants
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
n=5 Participants
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
n=6 Participants
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
n=5 Participants
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
n=4 Participants
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
n=5 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Antiviral Activity of MK7009
|
-1.90 Log10 IU/mL HCV RNA
Standard Deviation 0.40
|
-2.54 Log10 IU/mL HCV RNA
Standard Deviation 0.69
|
-2.80 Log10 IU/mL HCV RNA
Standard Deviation 0.96
|
-3.27 Log10 IU/mL HCV RNA
Standard Deviation 0.98
|
-4.62 Log10 IU/mL HCV RNA
Standard Deviation 0.39
|
-1.82 Log10 IU/mL HCV RNA
Standard Deviation 0.61
|
-2.35 Log10 IU/mL HCV RNA
Standard Deviation 0.21
|
0.11 Log10 IU/mL HCV RNA
Standard Deviation 0.18
|
Adverse Events
25 mg b.i.d. MK7009
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
75 mg b.i.d. MK7009
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
250 mg b.i.d. MK7009
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
500 mg b.i.d. MK7009
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
700 mg b.i.d. MK7009
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
125 mg q.d. MK7009
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
600 mg q.d. MK7009
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
25 mg b.i.d. MK7009
n=3 participants at risk
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
n=6 participants at risk
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
n=6 participants at risk
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
n=5 participants at risk
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
n=6 participants at risk
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
n=5 participants at risk
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
n=4 participants at risk
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
n=5 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
3/6
|
0.00%
0/5
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
40.0%
2/5
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
20.0%
1/5
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3
|
16.7%
1/6
|
16.7%
1/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
20.0%
1/5
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
20.0%
1/5
|
|
General disorders
Axillary Pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
20.0%
1/5
|
|
General disorders
Energy Increased
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
|
General disorders
Malaise
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
20.0%
1/5
|
|
General disorders
Pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
20.0%
1/5
|
|
General disorders
Vessel Puncture Site Pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Investigations
Blood Creatinine Increased
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Investigations
Blood Potassium Decreased
|
33.3%
1/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Investigations
Blood Urea Increased
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Investigations
Electrocardiogram PQ Interval Prolonged
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
16.7%
1/6
|
33.3%
2/6
|
0.00%
0/5
|
33.3%
2/6
|
40.0%
2/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
20.0%
1/5
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/3
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/4
|
0.00%
0/5
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/5
|
25.0%
1/4
|
0.00%
0/5
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER