Trial Outcomes & Findings for MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005) (NCT NCT04308304)
NCT ID: NCT04308304
Last Updated: 2024-08-15
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Up to Day 42
Results posted on
2024-08-15
Participant Flow
Male and female adult (≥50 to ≤85 years of age) participants with Alzheimer's disease (AD) and mild-to-moderate cognitive impairment were enrolled at 4 study centers in the United States.
Participant milestones
| Measure |
MK-1942 AD
Participants with AD receive donepezil 10 mg to 15 mg once daily (QD), and MK-1942 twice daily (BID), for 28 days. Doses of MK-1942 were 8 mg (Week 1), 15 mg (Week 2), 30 mg (Week 3) and 50 mg (Week 4).
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
5
|
|
Overall Study
COMPLETED
|
17
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
MK-1942 AD
Participants with AD receive donepezil 10 mg to 15 mg once daily (QD), and MK-1942 twice daily (BID), for 28 days. Doses of MK-1942 were 8 mg (Week 1), 15 mg (Week 2), 30 mg (Week 3) and 50 mg (Week 4).
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)
Baseline characteristics by cohort
| Measure |
MK-1942 AD
n=22 Participants
Participants with AD receive donepezil 10 mg to 15 mg once daily (QD), and MK-1942 twice daily (BID), for 28 days. Doses of MK-1942 were 8 mg (Week 1), 15 mg (Week 2), 30 mg (Week 3) and 50 mg (Week 4).
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
69.4 years
STANDARD_DEVIATION 2.6 • n=107 Participants
|
69.2 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to Day 42Population: All participants who received ≥1 dose of study treatment are included.
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.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ≥1 Adverse Event (AE)
|
13 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: All participants who received ≥1 dose of study treatment are included.
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.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants Discontinuing From Study Therapy Due to an Adverse Event (AE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: All participants who received ≥1 dose of study treatment are included.
The number of participants with clinically significant 12-lead ECGs is presented. Recordings were made throughout the study, with the participant in a semi-recumbent position having rested in this position for at least 10 minutes beforehand.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) Findings
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 29 daysPopulation: All participants who received ≥1 dose of study treatment are included.
The number of participants with abnormal (impaired) results on targeted neurological exams will be presented. The targeted neurological exam contains Modules 1, 2 and 5 of the general examination, focusing on arousal, cranial nerve function, and gait and will be administered several times throughout the treatment period starting on Day 1 up until Day 29. The number of participants with abnormal (impaired) results on targeted neurological exams will be reported. Each exam will be graded as Normal or Impaired with the abnormality described.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal (Impaired) Results on Targeted Neurological Exams
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 42 daysPopulation: All participants who received ≥1 dose of study treatment are included.
The number of participants with suicidality using the C-SSRS is presented. The C-SSR will be used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. C-SSRS assessment will be based upon a clinician's interpretation of the participant's responses to the C-SSRS questions, not by a numbered scale. Suicidal ideation and/or behaviors identified on the C-SSRS may not be considered an adverse event, based on the investigator's judgment. Participants who report at least one occurrence of suicidal behavior or suicidal ideation will be counted as having experienced suicidality. Suicidal behavior includes suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation include a wish to die or active suicidal thought with or without method, intent or plan.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants Who Reported Suicidal Ideation and/or Behavior on Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Days 1, 8, 15, and 22: 2 hours postdosePopulation: All participants who received ≥1 dose of study treatment are included.
The mean change from baseline in HR is presented. Change in HR was determined the first day of treatment with a new dose of MK-1942. A negative value indicates a decrease in HR relative to baseline, and a positive value indicates an increase.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate (HR)
|
-2.27 beats/min
Standard Error 1.25
|
2.56 beats/min
Standard Error 1.65
|
6.14 beats/min
Standard Error 2.27
|
0.21 beats/min
Standard Error 2.81
|
-4.53 beats/min
Standard Error 1.06
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Days 1, 8, 15, and 22: 2 hours postdosePopulation: All participants who received ≥1 dose of study treatment are included.
The mean change from baseline in SBP is presented. Change in SBP was determined the first day of treatment with a new dose of MK-1942. Negative values represent a decrease in SBP relative to baseline, and positive values represent an increase.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP)
|
2.48 mmHg
Standard Error 2.08
|
-0.15 mmHg
Standard Error 2.59
|
0.88 mmHg
Standard Error 2.09
|
1.45 mmHg
Standard Error 2.19
|
5.93 mmHg
Standard Error 4.00
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Days 1, 8, 15, and 22: 2 hours postdosePopulation: All participants who received ≥1 dose of study treatment are included.
The mean change from baseline in DBP is presented. Change in DBP was determined the first day of treatment with a new dose of MK-1942. Negative values represent a decrease in DBP relative to baseline, and positive values represent an increase.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure (DBP)
|
-0.95 mmHg
Standard Error 0.93
|
0.56 mmHg
Standard Error 2.01
|
1.17 mmHg
Standard Error 1.51
|
0.10 mmHg
Standard Error 1.39
|
-1.73 mmHg
Standard Error 3.36
|
PRIMARY outcome
Timeframe: Up to 42 daysPopulation: All participants who received ≥1 dose of study treatment are included.
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 number of participants with abnormal chemistry-related AEs is reported.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Clinical Chemistry Test Results Reported as Adverse Events
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 42 daysPopulation: All participants who received ≥1 dose of study treatment are included.
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 number of participants with abnormal hematology-related AEs is reported.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Clinical Hematology Test Results Reported as Adverse Events
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 42 daysPopulation: All participants who received ≥1 dose of study treatment are included.
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 number of participants with an abnormal urinalysis results AE is reported.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=22 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=19 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
n=5 Participants
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Results Reported as Adverse Events
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.
AUC0-12 is reported for the first day of treatment of each MK-1942 dose.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=18 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=17 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to 12 Hours Postdose (AUC0-12) of MK-1942
|
1760 hr*nmol/L
Interval 1390.0 to 2240.0
|
3580 hr*nmol/L
Interval 2860.0 to 4490.0
|
6650 hr*nmol/L
Interval 5330.0 to 8280.0
|
11600 hr*nmol/L
Interval 9110.0 to 14700.0
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.
AUC0-24 is reported for the first day of treatment of each MK-1942 dose. Due to twice daily dosing, AUC0-24 was calculated as "AUC0-24 = AUC0-12 x 2".
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=18 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=17 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
AUC From Dosing to 24 Hours Postdose (AUC0-24) of MK-1942
|
3530 hr*nmol/L
Interval 2790.0 to 4470.0
|
7160 hr*nmol/L
Interval 5710.0 to 8970.0
|
13330 hr*nmol/L
Interval 10700.0 to 16600.0
|
23200 hr*nmol/L
Interval 18200.0 to 29500.0
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.
Cmax is reported for the first day of treatment of each MK-1942 dose.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=18 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=17 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MK-1942
|
239 nmol/L
Interval 184.0 to 310.0
|
477 nmol/L
Interval 371.0 to 613.0
|
876 nmol/L
Interval 731.0 to 1050.0
|
1360 nmol/L
Interval 1080.0 to 1720.0
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.
Ctrough is reported for the first day of treatment of each MK-1942 dose. Data from healthy elderly participants used for statistical analyses are unpublished findings from study MK-1942-004.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=18 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=17 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of MK-1942
|
101 nmol/L
Interval 79.7 to 127.0
|
228 nmol/L
Interval 188.0 to 277.0
|
386 nmol/L
Interval 282.0 to 527.0
|
693 nmol/L
Interval 528.0 to 910.0
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.
Tmax is reported for the first day of treatment of each MK-1942 dose.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=18 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=17 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MK-1942
|
1.97 Hours
Interval 0.93 to 3.0
|
1.98 Hours
Interval 0.43 to 3.0
|
2.00 Hours
Interval 1.0 to 5.95
|
2.00 Hours
Interval 1.93 to 3.08
|
—
|
SECONDARY outcome
Timeframe: Day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.
t½ is reported for MK-1942 50 mg.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Apparent Terminal Plasma Half-Life (t½) of MK-1942
|
26.7 Hours
Geometric Coefficient of Variation 27.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.
CLss/F is reported for MK-1942 50 mg.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Apparent Clearance at Steady-state (CLss/F) of MK-1942
|
11.7 L/h
Geometric Coefficient of Variation 45.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. In addition, healthy control participant data is from study MK-1942-004.
Vzss/F is reported for MK-1942 50 mg.
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution at Steady State (Vzss/F) of MK-1942
|
449 Liters
Geometric Coefficient of Variation 41.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. The same participant's data are used for Day -1 and Day 28 when available.
AUC0-24 is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28). Due to twice daily dosing, AUC0-24 was calculated as "AUC0-12 x 2".
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=20 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
AUC0-24 of Donepezil
|
606 hr*ng/mL
Geometric Coefficient of Variation 66.4
|
919 hr*ng/mL
Geometric Coefficient of Variation 44.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. The same participant's data are used for Day -1 and Day 28 when available.
Cmax is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=20 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Cmax of Donepezil
|
37.9 ng/mL
Geometric Coefficient of Variation 56.4
|
53.3 ng/mL
Geometric Coefficient of Variation 42.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. The same participant's data are used for Day -1 and Day 28 when available.
Ctrough is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=20 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Ctrough of Donepezil
|
20.1 ng/mL
Geometric Coefficient of Variation 72.7
|
31.8 ng/mL
Geometric Coefficient of Variation 52.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 7, 14, and 21 (morning dose only): predose and 0.5, 1, 2, 3, 4, 6, and 12 hours postdosePopulation: A subset of treated participants who complied with the protocol sufficiently to ensure the data are likely to reflect the underlying scientific model, are included. The same participant's data are used for Day -1 and Day 28 when available.
Tmax is reported for donepezil 10 mg alone (Day -1) or with MK-1942 50 mg (Day 28).
Outcome measures
| Measure |
MK-1942 8 mg + Donepezil AD
n=20 Participants
Participants with AD received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg + Donepezil AD
n=15 Participants
Participants with AD received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg + Donepezil AD
Participants with AD received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg + Donepezil AD
Participants with AD received MK-1942 50 mg + donepezil during Week 4.
|
Placebo + Donepezil AD
Participants with AD receive donepezil 10 mg to 15 mg QD, and placebo BID, for 28 days.
|
|---|---|---|---|---|---|
|
Tmax of Donepezil
|
2.05 Hours
Interval 0.0 to 4.0
|
2.03 Hours
Interval 1.0 to 3.95
|
—
|
—
|
—
|
Adverse Events
MK-1942 8 mg BID 7 Days
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
MK-1942 15 mg BID 7 Days
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-1942 30 mg Bid 7D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-1942 50 mg BID & Days
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-1942 Total
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo Bid
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-1942 8 mg BID 7 Days
n=22 participants at risk
Participants received MK-1942 8 mg + donepezil during Week 1.
|
MK-1942 15 mg BID 7 Days
n=19 participants at risk
Participants received MK-1942 15 mg + donepezil during Week 2.
|
MK-1942 30 mg Bid 7D
n=15 participants at risk
Participants received MK-1942 30 mg + donepezil during Week 3.
|
MK-1942 50 mg BID & Days
n=15 participants at risk
Participants received MK-1942 50 mg + donepezil during Week 4.
|
MK-1942 Total
n=22 participants at risk
Participants received MK-1924 8 mg, 15 mg, 30 mg, and 50 mg during Weeks 1, 2, 3, and 4, respectively.
|
Placebo Bid
n=5 participants at risk
Participants received placebo + donepezil for 7 days.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Scleral hyperaemia
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Eye disorders
Scleritis
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Eye disorders
Vision blurred
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
5.3%
1/19 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
9.1%
2/22 • Number of events 2 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Gastrointestinal disorders
Nausea
|
22.7%
5/22 • Number of events 5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
5.3%
1/19 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
13.3%
2/15 • Number of events 3 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
31.8%
7/22 • Number of events 9 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
40.0%
2/5 • Number of events 2 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Number of events 2 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
5.3%
1/19 • Number of events 2 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
9.1%
2/22 • Number of events 4 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
General disorders
Gait disturbance
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
General disorders
Medical device site injury
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 2 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Investigations
Blood sodium decreased
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Investigations
Electrocardiogram QT prolonged
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Investigations
Electrocardiogram T wave biphasic
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
5.3%
1/19 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 2 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Nervous system disorders
Balance disorder
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Nervous system disorders
Dizziness
|
13.6%
3/22 • Number of events 3 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
13.3%
2/15 • Number of events 2 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
22.7%
5/22 • Number of events 5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Nervous system disorders
Dizziness postural
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Nervous system disorders
Dystonia
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
40.0%
2/5 • Number of events 2 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Nervous system disorders
Nystagmus
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
6.7%
1/15 • Number of events 2 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
13.6%
3/22 • Number of events 4 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
20.0%
1/5 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
5.3%
1/19 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/22 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
6.7%
1/15 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/19 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/15 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
4.5%
1/22 • Number of events 1 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
0.00%
0/5 • Up to 42 days
All participants who received ≥1 dose of study treatment are included. Safety is reported according to MK-1942 dose or placebo treatment received.
|
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 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