Trial Outcomes & Findings for Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis (MK-2060-004) (NCT NCT03873038)
NCT ID: NCT03873038
Last Updated: 2024-06-06
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants that experienced an AE was summarized.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Up to 164 days
Results posted on
2024-06-06
Participant Flow
Male and Female of non-childbearing potential (WONCBP) participants with end-stage renal disease (ESRD) on hemodialysis (HD) between the ages of 18 and 80 years (ages ≥ 40 and ≤ 80 for Part 1 and ≥ 18 and ≤ 80 for Part 2) were enrolled in this study.
Participant milestones
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
Participants received a single 8-mg dose of MK-2060 via intravenous (IV) infusion
|
Part 1: Panel B- MK-2060 (20 mg)
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel C- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance
Participants received three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4)
|
Part 2: Placebo
Participants received three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4)
|
|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
6
|
7
|
6
|
5
|
0
|
0
|
|
Part 1
COMPLETED
|
6
|
7
|
6
|
5
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
0
|
16
|
5
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
15
|
4
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
Participants received a single 8-mg dose of MK-2060 via intravenous (IV) infusion
|
Part 1: Panel B- MK-2060 (20 mg)
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel C- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance
Participants received three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4)
|
Part 2: Placebo
Participants received three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4)
|
|---|---|---|---|---|---|---|
|
Part 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2
Unknon
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis (MK-2060-004)
Baseline characteristics by cohort
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel C- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
n=5 Participants
Participants received a single dose of placebo via IV infusion
|
Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance
n=10 Participants
Participants received three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4)
|
Part 2: Placebo
n=4 Participants
Participants received three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4)
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.8 Years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
61.1 Years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
58.2 Years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
60.0 Years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
54.7 Years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
52.5 Years
STANDARD_DEVIATION 11.6 • n=8 Participants
|
57.2 Years
STANDARD_DEVIATION 6.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 164 daysPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants that experienced an AE was summarized.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
n=5 Participants
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With Any Adverse Event (AE)
|
16.7 Percentage of Participants
|
57.1 Percentage of Participants
|
66.7 Percentage of Participants
|
60.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 118 daysPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE was summarized.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=16 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=5 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With Any AE
|
12.5 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 164 daysPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
n=5 Participants
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With Any Serious Adverse Event
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
16.7 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 118 daysPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced an SAE was summarized.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=16 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=5 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With Any SAE
|
6.3 Percentage of Participants
|
60.0 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 164 daysPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
n=5 Participants
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With a Systemic AE
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 118 daysPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The solicited systemic AEs assessed included but not limited to fever, vital sign (VS) changes (tachycardia/hypotension), pruritis, urticarial (hives), lip swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=16 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=5 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With a Systemic AE
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 164 daysPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
n=5 Participants
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With an Injection-Site AE
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 118 daysPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The solicited injection-site AEs assessed were pain, tenderness, erythema/redness, and induration/swelling.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=16 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=5 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants With an Injection-Site AE
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 164 daysPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants that discontinued the study due to an AE was summarized.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
n=5 Participants
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Discontinuing the Study Due to an AE
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants that had study drug discontinued regardless of study completion status was summarized.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=16 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=5 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants Discontinuing Study Drug Due to an AE
|
0.0 Percentage of Participants
|
40.0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150Population: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and AUC0-inf was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From 0 to Infinity (AUC0-inf)
|
4550 hr*nmol/Liter
Geometric Coefficient of Variation 61.2
|
6520 hr*nmol/Liter
Geometric Coefficient of Variation 63.4
|
15100 hr*nmol/Liter
Geometric Coefficient of Variation 31.7
|
—
|
SECONDARY outcome
Timeframe: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdosePopulation: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and AUC0-168 hours was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=5 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours (AUC0-168)
|
1560 hr*nmol/Liter
Geometric Coefficient of Variation 32.5
|
2420 hr*nmol/Liter
Geometric Coefficient of Variation 47.0
|
4930 hr*nmol/Liter
Geometric Coefficient of Variation 26.8
|
—
|
SECONDARY outcome
Timeframe: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdose, then Days 12, 15, 22, 29, 60, 90, 120, 150Population: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and Cmax was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of MK-2060
|
14.8 nmol/Liter
Geometric Coefficient of Variation 38.2
|
28.0 nmol/Liter
Geometric Coefficient of Variation 49.3
|
61.3 nmol/Liter
Geometric Coefficient of Variation 19.3
|
—
|
SECONDARY outcome
Timeframe: 168 hours post dosePopulation: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at 168 hours post-dose and C168 was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=5 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Plasma Concentration of MK-2060 at 168 Hours (C168)
|
6.29 nmol/Liter
Geometric Coefficient of Variation 41.6
|
9.10 nmol/Liter
Geometric Coefficient of Variation 57.7
|
15.8 nmol/Liter
Geometric Coefficient of Variation 30.2
|
—
|
SECONDARY outcome
Timeframe: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdosePopulation: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and Tmax was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-2060
|
1.13 Hours
Interval 0.75 to 12.0
|
0.97 Hours
Interval 0.83 to 12.0
|
1.09 Hours
Interval 0.9 to 12.0
|
—
|
SECONDARY outcome
Timeframe: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdosePopulation: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples was collected at pre-specified time points post-dose and t ½ was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Plasma Elimination Terminal Half-life (t ½) of MK-2060
|
325 Hours
Geometric Coefficient of Variation 88.5
|
422 Hours
Geometric Coefficient of Variation 69.0
|
508 Hours
Geometric Coefficient of Variation 21.7
|
—
|
SECONDARY outcome
Timeframe: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdosePopulation: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and CL was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Plasma Clearance (CL) of MK-2060
|
0.0119 Liters/hour
Geometric Coefficient of Variation 61.2
|
0.0207 Liters/hour
Geometric Coefficient of Variation 63.4
|
0.0179 Liters/hour
Geometric Coefficient of Variation 31.7
|
—
|
SECONDARY outcome
Timeframe: Predose Day 1 and 1, 12, 24, 48, 52, 96, 168 hours postdosePopulation: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and Vz was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 1: Plasma Volume of Distribution (Vz) of MK-2060
|
5.56 Liters
Geometric Coefficient of Variation 49.0
|
12.6 Liters
Geometric Coefficient of Variation 65.3
|
13.1 Liters
Geometric Coefficient of Variation 31.2
|
—
|
SECONDARY outcome
Timeframe: Up to 168 hours on Day 1 and Day 22Population: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and AUC0-168 hours was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=15 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 2: AUC0-168 of MK-2060
Day 1
|
2290 hr*nmol/L
Geometric Coefficient of Variation 26.8
|
—
|
—
|
—
|
|
Part 2: AUC0-168 of MK-2060
Day 22
|
9880 hr*nmol/L
Geometric Coefficient of Variation 28.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 22Population: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and Cmax was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=16 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 2: Cmax of MK-2060
Day 1
|
32.6 nmol/Liter
Geometric Coefficient of Variation 32.5
|
—
|
—
|
—
|
|
Part 2: Cmax of MK-2060
Day 22
|
90.9 nmol/Liter
Geometric Coefficient of Variation 30.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 168 hours post dose on Days 1 and 22Population: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at 168 hours post-dose and C168 was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=15 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 2: C168 of MK-2060
Day 1
|
54.1 nmol/Liter
Geometric Coefficient of Variation 42.1
|
—
|
—
|
—
|
|
Part 2: C168 of MK-2060
Day 22
|
43.8 nmol/Liter
Geometric Coefficient of Variation 30.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 22Population: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and Tmax was assessed.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=16 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Part 2: Tmax of MK-2060
Day 1
|
1.00 Hours
Interval 0.92 to 47.92
|
—
|
—
|
—
|
|
Part 2: Tmax of MK-2060
Day 22
|
1.00 Hours
Interval 0.0 to 24.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 168 hours post-dose (Day 8)Population: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and aPTT values were assessed. The fold change (Day 8/Baseline) at Day 8 was reported.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=5 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
n=6 Participants
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
n=5 Participants
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) of MK-2060: Part 1
|
1.04 Ratio
Interval 0.92 to 1.18
|
1.17 Ratio
Interval 1.06 to 1.3
|
1.52 Ratio
Interval 1.36 to 1.71
|
1.05 Ratio
Interval 0.92 to 1.19
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: Per-Protocol Population which consisted of the set of data generated by the subset of participants who had evaluable data for the endpoint and who complied with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Plasma samples were collected at pre-specified time points post-dose and aPTT values were assessed. The fold change (Day 8/Baseline) at Day 8 was reported.
Outcome measures
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=15 Participants
Participants received a single 8-mg dose of MK-2060 via IV infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=4 Participants
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel A- MK-2060 (40 mg)
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
Participants received a single dose of placebo via IV infusion
|
|---|---|---|---|---|
|
Fold Change From Baseline in aPTT of MK-2060: Part 2
|
2.46 Ratio
Interval 1.95 to 3.11
|
0.68 Ratio
Interval 0.43 to 1.06
|
—
|
—
|
Adverse Events
Part 1: Panel A- MK-2060 (8 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Panel B- MK-2060 (20 mg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: Panel C- MK-2060 (40 mg)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: Placebo
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 participants at risk
Participants received a single 8-mg dose of MK-2060 via intravenous (IV) infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 participants at risk
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel C- MK-2060 (40 mg)
n=6 participants at risk
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
n=5 participants at risk
Participants received a single dose of placebo via IV infusion
|
Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance
n=16 participants at risk
Participants received three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4)
|
Part 2: Placebo
n=5 participants at risk
Participants received three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4)
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
6.2%
1/16 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
16.7%
1/6 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
Other adverse events
| Measure |
Part 1: Panel A- MK-2060 (8 mg)
n=6 participants at risk
Participants received a single 8-mg dose of MK-2060 via intravenous (IV) infusion
|
Part 1: Panel B- MK-2060 (20 mg)
n=7 participants at risk
Participants received a single 20-mg dose of MK-2060 via IV infusion
|
Part 1: Panel C- MK-2060 (40 mg)
n=6 participants at risk
Participants received a single 40-mg dose of MK-2060 via IV infusion
|
Part 1: Placebo
n=5 participants at risk
Participants received a single dose of placebo via IV infusion
|
Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance
n=16 participants at risk
Participants received three doses of up to 25 mg MK-2060 via IV infusion in the first week (Week 1), followed by a single dose of up to 25 mg MK-2060 via IV infusion weekly for 3 weeks (Weeks 2-4)
|
Part 2: Placebo
n=5 participants at risk
Participants received three doses of placebo via IV infusion in the first week and then a single dose of placebo via IV infusion weekly for 3 weeks (Weeks 2-4)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
40.0%
2/5 • Number of events 2 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
6.2%
1/16 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
14.3%
1/7 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
14.3%
1/7 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
16.7%
1/6 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
14.3%
1/7 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
14.3%
1/7 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
16.7%
1/6 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Investigations
Occult blood positive
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
14.3%
1/7 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
33.3%
2/6 • Number of events 2 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
14.3%
1/7 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
16.7%
1/6 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
20.0%
1/5 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
16.7%
1/6 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
16.7%
1/6 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
16.7%
1/6 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
6.2%
1/16 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
16.7%
1/6 • Number of events 1 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/7 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/6 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/16 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
0.00%
0/5 • Up to 164 days
Analysis population was the All Subjects as Treated Population which consisted of all participants who received at least one dose of treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. The Sponsor will comply with the requirements for publication of study results. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER