Trial Outcomes & Findings for A Study To Evaluate The Effect Of A Supratherapeutic Dose Of MK-8189 On The QTc Interval In Participants With Schizophrenia (MK-8189-019) (NCT NCT05893862)
NCT ID: NCT05893862
Last Updated: 2025-04-22
Results Overview
Electrocardiogram data was obtained using a digital Holter device and the Fridericia correction of the QT interval (QTcF) was determined. The change from baseline in QTcF (ΔQTcF \[msec\]) was calculated by subtracting the QTcF value at the timepoint from the QTcF baseline value. Negative values represent a decrease from baseline and vice versa. An average of up to 9 predose ECGs on Day 1 served as baseline to compare postdose effects. Per protocol, the primary endpoint compares MK-8189 to placebo.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
107 participants
Primary outcome timeframe
Day 1 (MK-8189 48 mg and placebo) and Day 2 (MK-8189 80 mg and placebo)
Results posted on
2025-04-22
Participant Flow
Participants with stable schizophrenia or schizoaffective disorder were enrolled at 4 study sites in the US.
Treatments were administered in a counterbalanced manner on Day 1 and Day 2 of each of 3 treatment periods. Periods 1 and 2 were separated by 5-day washout. 'A' refers to MK-8189 48 mg (Day 1) and 80 mg (Day 2); 'B' refers to Standard Image Placebo (Day 1) and Moxifloxacin 400 mg (Day 2); and 'C' refers to placebo to MK-8189 (Days 1 and 2).
Participant milestones
| Measure |
Sequence A/B/C
Participants received treatment sequence A/B/C.
|
Sequence A/C/B
Participants received treatment sequence A/C/B.
|
Sequence B/A/C
Participants received treatment sequence B/A/C.
|
Sequence B/C/A
Participants received treatment sequence B/C/A.
|
Sequence C/A/B
Participants received treatment sequence C/A/B.
|
Sequence C/B/A
Participants received treatment sequence C/B/A.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
25
|
15
|
18
|
20
|
14
|
|
Overall Study
Treatment Period 1 + 5 Day Washout
|
15
|
25
|
15
|
18
|
20
|
14
|
|
Overall Study
Treatment Period 2 + 5 Day Washout
|
14
|
16
|
15
|
15
|
18
|
14
|
|
Overall Study
Treatment Period 3
|
13
|
13
|
12
|
13
|
15
|
12
|
|
Overall Study
COMPLETED
|
13
|
13
|
12
|
13
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
12
|
3
|
5
|
5
|
2
|
Reasons for withdrawal
| Measure |
Sequence A/B/C
Participants received treatment sequence A/B/C.
|
Sequence A/C/B
Participants received treatment sequence A/C/B.
|
Sequence B/A/C
Participants received treatment sequence B/A/C.
|
Sequence B/C/A
Participants received treatment sequence B/C/A.
|
Sequence C/A/B
Participants received treatment sequence C/A/B.
|
Sequence C/B/A
Participants received treatment sequence C/B/A.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
1
|
3
|
3
|
2
|
|
Overall Study
Adverse Event
|
1
|
4
|
2
|
2
|
1
|
0
|
Baseline Characteristics
A Study To Evaluate The Effect Of A Supratherapeutic Dose Of MK-8189 On The QTc Interval In Participants With Schizophrenia (MK-8189-019)
Baseline characteristics by cohort
| Measure |
Sequence A/B/C
n=15 Participants
Participants received treatment sequence A/B/C.
|
Sequence ACB
n=25 Participants
Participants received treatment sequence A/C/B.
|
Sequence B/A/C
n=15 Participants
Participants received treatment sequence B/A/C.
|
Sequence B/C/A
n=18 Participants
Participants received treatment sequence B/C/A.
|
Sequence C/A/B
n=20 Participants
Participants received treatment sequence C/A/B.
|
Sequence C/B/A
n=14 Participants
Participants received treatment sequence C/B/A.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
44.1 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
45.9 years
STANDARD_DEVIATION 11.2 • n=8 Participants
|
45.4 years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
83 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
94 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 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
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
86 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
16 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 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: Day 1 (MK-8189 48 mg and placebo) and Day 2 (MK-8189 80 mg and placebo)Population: All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included.
Electrocardiogram data was obtained using a digital Holter device and the Fridericia correction of the QT interval (QTcF) was determined. The change from baseline in QTcF (ΔQTcF \[msec\]) was calculated by subtracting the QTcF value at the timepoint from the QTcF baseline value. Negative values represent a decrease from baseline and vice versa. An average of up to 9 predose ECGs on Day 1 served as baseline to compare postdose effects. Per protocol, the primary endpoint compares MK-8189 to placebo.
Outcome measures
| Measure |
MK-8189 48 mg Day 1
n=95 Participants
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
n=87 Participants
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
n=91 Participants
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
n=84 Participants
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
Predose (Day 2 only)
|
—
|
—
|
4.31 ΔQTcF (msec)
Interval 2.45 to 6.16
|
-1.38 ΔQTcF (msec)
Interval -3.24 to 0.49
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
0.5 Hr
|
-0.61 ΔQTcF (msec)
Interval -1.87 to 0.66
|
-1.13 ΔQTcF (msec)
Interval -2.84 to 0.57
|
—
|
—
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
1 hr
|
0.29 ΔQTcF (msec)
Interval -1.5 to 2.08
|
0.48 ΔQTcF (msec)
Interval -1.25 to 2.2
|
3.60 ΔQTcF (msec)
Interval 1.33 to 5.87
|
-0.76 ΔQTcF (msec)
Interval -2.95 to 1.43
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
2 hr
|
2.68 ΔQTcF (msec)
Interval 0.21 to 5.16
|
1.06 ΔQTcF (msec)
Interval -1.35 to 3.46
|
5.14 ΔQTcF (msec)
Interval 2.4 to 7.87
|
0.92 ΔQTcF (msec)
Interval -1.74 to 3.58
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
3 hr
|
2.18 ΔQTcF (msec)
Interval -0.61 to 4.97
|
-1.35 ΔQTcF (msec)
Interval -4.03 to 1.34
|
3.31 ΔQTcF (msec)
Interval 0.5 to 6.11
|
-2.22 ΔQTcF (msec)
Interval -5.17 to 0.72
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
4 hr
|
2.80 ΔQTcF (msec)
Interval 0.07 to 5.53
|
-3.19 ΔQTcF (msec)
Interval -5.73 to -0.64
|
2.64 ΔQTcF (msec)
Interval 0.11 to 5.16
|
-2.67 ΔQTcF (msec)
Interval -5.4 to 0.05
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
6 hr (Day 1 only)
|
7.38 ΔQTcF (msec)
Interval 4.75 to 10.0
|
0.25 ΔQTcF (msec)
Interval -2.51 to 3.02
|
—
|
-3.10 ΔQTcF (msec)
Interval -5.82 to -0.39
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
8 hr
|
8.75 ΔQTcF (msec)
Interval 6.51 to 10.98
|
-0.97 ΔQTcF (msec)
Interval -3.57 to 1.64
|
2.82 ΔQTcF (msec)
Interval 0.25 to 5.4
|
-1.93 ΔQTcF (msec)
Interval -4.83 to 0.98
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
12 hr (Day 1) or 11 hr (Day 2)
|
4.26 ΔQTcF (msec)
Interval 1.41 to 7.11
|
0.33 ΔQTcF (msec)
Interval -2.12 to 2.79
|
3.84 ΔQTcF (msec)
Interval 0.95 to 6.73
|
0.84 ΔQTcF (msec)
Interval -2.54 to 4.22
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
14 hr
|
8.10 ΔQTcF (msec)
Interval 5.33 to 10.86
|
4.09 ΔQTcF (msec)
Interval 1.66 to 6.53
|
7.84 ΔQTcF (msec)
Interval 7.53 to 13.42
|
5.20 ΔQTcF (msec)
Interval 2.23 to 8.17
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
16 hr (Day 2 only)
|
—
|
—
|
10.47 ΔQTcF (msec)
Interval 7.53 to 13.42
|
5.20 ΔQTcF (msec)
Interval 2.23 to 8.17
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment
24 hr
|
4.31 ΔQTcF (msec)
Interval 2.45 to 6.16
|
-1.38 ΔQTcF (msec)
Interval -3.24 to 0.49
|
0.24 ΔQTcF (msec)
Interval -2.37 to 2.85
|
-1.61 ΔQTcF (msec)
Interval -3.22 to -0.01
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to ~30 days after each dosePopulation: All treated participants 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-8189 48 mg Day 1
n=98 Participants
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
n=90 Participants
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
n=92 Participants
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
n=89 Participants
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
n=89 Participants
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
25 Participants
|
16 Participants
|
21 Participants
|
7 Participants
|
11 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to ~30 days after each dosePopulation: All treated participants 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-8189 48 mg Day 1
n=98 Participants
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
n=90 Participants
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
n=92 Participants
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
n=89 Participants
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
n=89 Participants
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing Study Therapy Due to AE
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: All participants who received ≥1 dose of moxifloxacin, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included.
Electrocardiogram data was obtained using a digital Holter device and the Fridericia correction of the QT interval (QTcF) was determined. The change from baseline in QTcF (ΔQTcF \[msec\]) was calculated by subtracting the QTcF value at the timepoint from the QTcF baseline value. Negative values represent a decrease from baseline and vice versa. An average of up to 9 predose ECGs on Day 1 served as baseline to compare postdose effects. Per protocol, the secondary endpoint compares moxifloxacin to placebo on Day 2. Moxifloxacin was tested for statistical significance 1 to 4 hours postdose (ie, around moxifloxacin Cmax) to ensure assay sensitivity. Hochberg's step-up method was applied to preserve the overall α level at .05 for the hypothesis testing.
Outcome measures
| Measure |
MK-8189 48 mg Day 1
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
n=84 Participants
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
n=84 Participants
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
Predose (Day 2 only)
|
—
|
—
|
—
|
-1.38 ΔQTcF (msec)
Interval -3.24 to 0.49
|
—
|
0.92 ΔQTcF (msec)
Interval -0.8 to 2.65
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
0.5 hr (Day 1 only)
|
—
|
—
|
—
|
-1.38 ΔQTcF (msec)
Interval -3.24 to 0.49
|
—
|
—
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
1 hr
|
—
|
—
|
—
|
-0.76 ΔQTcF (msec)
Interval -2.95 to 1.43
|
—
|
9.77 ΔQTcF (msec)
Interval 7.34 to 12.2
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
2 hr
|
—
|
—
|
—
|
0.92 ΔQTcF (msec)
Interval -1.74 to 3.58
|
—
|
11.03 ΔQTcF (msec)
Interval 8.53 to 13.53
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
3 hr
|
—
|
—
|
—
|
-2.22 ΔQTcF (msec)
Interval -5.17 to 0.72
|
—
|
8.92 ΔQTcF (msec)
Interval 6.28 to 11.57
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
4 hr
|
—
|
—
|
—
|
-2.67 ΔQTcF (msec)
Interval -5.4 to 0.05
|
—
|
4.70 ΔQTcF (msec)
Interval 1.84 to 7.57
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
8 hr
|
—
|
—
|
—
|
-3.10 ΔQTcF (msec)
Interval -5.82 to -0.39
|
—
|
3.50 ΔQTcF (msec)
Interval 1.05 to 5.95
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
11 hr
|
—
|
—
|
—
|
-1.93 ΔQTcF (msec)
Interval -4.83 to 0.98
|
—
|
5.45 ΔQTcF (msec)
Interval 2.85 to 8.04
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
14 hr
|
—
|
—
|
—
|
0.84 ΔQTcF (msec)
Interval -2.54 to 4.22
|
—
|
10.12 ΔQTcF (msec)
Interval 6.9 to 13.35
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
16 hr
|
—
|
—
|
—
|
5.20 ΔQTcF (msec)
Interval 2.23 to 8.17
|
—
|
12.48 ΔQTcF (msec)
Interval 9.37 to 15.59
|
|
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Treatment
24 hr
|
—
|
—
|
—
|
-.61 ΔQTcF (msec)
Interval -3.22 to -0.01
|
—
|
2.33 ΔQTcF (msec)
Interval -0.08 to 4.74
|
SECONDARY outcome
Timeframe: Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24 hours postdosePopulation: All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included.
AUC0-24 is defined as the area under concentration-time curve from 0 to 24 hours postdose. Blood samples taken at pre-dose and up to 24 hours post-dose will be used to determine the AUC0-24 of MK-8189.
Outcome measures
| Measure |
MK-8189 48 mg Day 1
n=91 Participants
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
n=87 Participants
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of MK-8189
|
18500 hr*nM
Geometric Coefficient of Variation 50.2
|
—
|
41200 hr*nM
Geometric Coefficient of Variation 54.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, and 72 hours postdosePopulation: All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included.
AUC0-last is defined as the area under concentration-time curve from 0 to 24 hours. Blood samples taken at pre-dose and up to 72 hours post-dose will be used to extrapolate the AUC0-last of MK-8189.
Outcome measures
| Measure |
MK-8189 48 mg Day 1
n=96 Participants
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
n=91 Participants
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-8189
|
17400 hr*nM
Geometric Coefficient of Variation 61.6
|
—
|
54100 hr*nM
Geometric Coefficient of Variation 95.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, 72 hours postdosePopulation: All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included.
Cmax is the maximum plasma concentration of MK-8189.
Outcome measures
| Measure |
MK-8189 48 mg Day 1
n=96 Participants
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
n=91 Participants
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of MK-8189
|
1290 nM
Geometric Coefficient of Variation 50.6
|
—
|
2360 nM
Geometric Coefficient of Variation 52.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2: 24 hours postdosePopulation: All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included.
C24 is the plasma concentration 24 hours postdose.
Outcome measures
| Measure |
MK-8189 48 mg Day 1
n=91 Participants
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
n=86 Participants
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Concentration of MK-8189 at 24 Hours (C24) Post-dose
|
992 nM
Geometric Coefficient of Variation 83.7
|
—
|
1660 nM
Geometric Coefficient of Variation 87.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, 72 hours postdosePopulation: All participants who received MK-8189 80 mg, had sufficient terminal phase data, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included.
t½ is the time required for the Cmax plasma concentration to reduce by 50%. Per protocol, t½ was determined only for MK-8189 80 mg.
Outcome measures
| Measure |
MK-8189 48 mg Day 1
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
n=85 Participants
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t½) of MK-8189
|
—
|
9.89 hours
Geometric Coefficient of Variation 29.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, and 24 hours postdose; Day 2: 0.5, 1, 2, 3, 4, 8, 11, 14, 16, 24, 36, 48, and 72 hours postdosePopulation: All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included.
Tmax is defined as the time to reach Cmax.
Outcome measures
| Measure |
MK-8189 48 mg Day 1
n=96 Participants
Participants received a single dose of MK-8189 48 mg.
|
Placebo Day 1
n=91 Participants
Participants received a single dose of placebo.
|
MK-8189 80 mg Day 2
Participants received a single dose of MK-8189 80 mg.
|
Placebo Day 2
Participants received a single dose of placebo.
|
Standard Image Placebo Day 1
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
Participants received a single dose of moxifloxacin 400 mg on Day 2. Standard image placebo was given on Day 1 (open-label).
|
|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-8189
|
14.08 hours
Interval 6.13 to 25.42
|
14.13 hours
Interval 0.0 to 35.95
|
—
|
—
|
—
|
—
|
Adverse Events
MK-8189 48 mg
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
MK-8189 80 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
MK-8189 Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Standard Image Placebo Day 1
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Moxifloxacin 400 mg Day 2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-8189 48 mg
n=98 participants at risk
Participants received a single dose of MK-8189 48 mg on Day 1.
|
MK-8189 80 mg
n=92 participants at risk
Participants received a single dose of MK-8189 80 mg on Day 2.
|
MK-8189 Placebo
n=90 participants at risk
Participants received placebo on Day 1 and Day 2.
|
Standard Image Placebo Day 1
n=89 participants at risk
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
n=89 participants at risk
Participants received a single dose of moxifloxacin 400 mg on Day 2.
|
|---|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
Other adverse events
| Measure |
MK-8189 48 mg
n=98 participants at risk
Participants received a single dose of MK-8189 48 mg on Day 1.
|
MK-8189 80 mg
n=92 participants at risk
Participants received a single dose of MK-8189 80 mg on Day 2.
|
MK-8189 Placebo
n=90 participants at risk
Participants received placebo on Day 1 and Day 2.
|
Standard Image Placebo Day 1
n=89 participants at risk
Participants received a single dose of standard image placebo on Day 1.
|
Moxifloxacin 400 mg Day 2
n=89 participants at risk
Participants received a single dose of moxifloxacin 400 mg on Day 2.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Sedation
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
3.3%
3/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
2.2%
2/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Eye disorders
Excessive eye blinking
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
2.2%
2/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
2.2%
2/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
3.3%
3/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
4/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
4.3%
4/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
General disorders
Asthenia
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
General disorders
Application site injury
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
General disorders
Chest pain
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
General disorders
Fatigue
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
2.2%
2/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
General disorders
Medical device site irritation
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
General disorders
Withdrawal Syndrome
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Infections and infestations
COVID-19
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Investigations
Blood glucose increased
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Investigations
Blood pressure increased
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Investigations
Heart rate increased
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Investigations
Orthostatic heart rate response increased
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
3.3%
3/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Akathisia
|
3.1%
3/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
4.3%
4/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Dizziness
|
2.0%
2/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Dysarthria
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Dyskinesia
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Dystonia
|
5.1%
5/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Headache
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
5.6%
5/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Oromandibular dystonia
|
3.1%
3/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Somnolence
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Syncope
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Tardive dyskinesia
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Nervous system disorders
Tremor
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
2.2%
2/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Bruxism
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Disorientation
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Hallucination
|
1.0%
1/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
2.2%
2/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
2/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
2.2%
2/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Schizoprenia
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
2.2%
2/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
2.2%
2/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Psychiatric disorders
Hallucinations auditory
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
|
Vascular disorders
Hypotension
|
0.00%
0/98 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/92 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/90 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
1.1%
1/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
0.00%
0/89 • Up to ~30 days after each dose
All treated participants are included. Treatments were administered on Day 1 and Day 2.
|
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. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER