Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and Healthy Participants (MK-8189-011) (NCT NCT04506905)
NCT ID: NCT04506905
Last Updated: 2024-10-02
Results Overview
The number of participants with ≥1 AE is reported. 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
63 participants
Primary outcome timeframe
Up to approximately 27 days
Results posted on
2024-10-02
Participant Flow
Participants were enrolled at 6 study centers in USA.
Participant milestones
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
14
|
0
|
12
|
0
|
5
|
13
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
14
|
0
|
9
|
0
|
5
|
13
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and Healthy Participants (MK-8189-011)
Baseline characteristics by cohort
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=6 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=14 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=12 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
n=13 Participants
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
n=6 Participants
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
n=7 Participants
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
—
|
64.2 years
STANDARD_DEVIATION 2.0 • n=4 Participants
|
—
|
69.4 years
STANDARD_DEVIATION 2.3 • n=10 Participants
|
68.4 years
STANDARD_DEVIATION 3.6 • n=115 Participants
|
43.3 years
STANDARD_DEVIATION 8.6 • n=24 Participants
|
66.3 years
STANDARD_DEVIATION 4.7 • n=42 Participants
|
57.4 years
STANDARD_DEVIATION 13.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 27 daysPopulation: All randomized and treated participants are included.
The number of participants with ≥1 AE is reported. 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 |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=6 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=14 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=12 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
n=13 Participants
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
n=6 Participants
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
n=7 Participants
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 & 2: Number of Participants Who Experienced an Adverse Event (AE)
|
4 Participants
|
9 Participants
|
—
|
3 Participants
|
—
|
2 Participants
|
8 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 27 daysPopulation: All randomized and treated participants are included.
The number of participants discontinuing from study treatment due to ≥1 AE is reported. 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 |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=6 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=14 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=12 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
n=13 Participants
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
n=6 Participants
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
n=7 Participants
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 & 2: Number of Participants Discontinuing Study Treatment Due to an AE
|
0 Participants
|
1 Participants
|
—
|
2 Participants
|
—
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, and Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 1 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
AUC0-24 was determined for participants in Part 1 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=6 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=5 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=5 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=14 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
n=13 Participants
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=10 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration Time-curve From Hour 0 to 24 Hours Postdose (AUC0-24) of MK-8189
|
10500 hr*nmol/L
Interval 6210.0 to 17600.0
|
21200 hr*nmol/L
Interval 12600.0 to 35800.0
|
22700 hr*nmol/L
Interval 13500.0 to 38300.0
|
12500 hr*nmol/L
Interval 9920.0 to 15900.0
|
17600 hr*nmol/L
Interval 13800.0 to 22300.0
|
20500 hr*nmol/L
Interval 16000.0 to 26300.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 4, and Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 1 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
C24 was determined for participants in Part 1 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=6 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=5 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=5 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=14 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
n=13 Participants
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=10 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Concentration 24 Hours Postdose (C24) of MK-8189
|
615 nmol/L
Interval 225.0 to 1680.0
|
322 nmol/L
Interval 107.0 to 968.0
|
669 nmol/L
Interval 223.0 to 2010.0
|
565 nmol/L
Interval 389.0 to 821.0
|
567 nmol/L
Interval 387.0 to 830.0
|
666 nmol/L
Interval 445.0 to 997.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, and Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 1 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Cmax was determined for participants in Part 1 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=6 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=5 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=5 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=14 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
n=13 Participants
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=13 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
n=10 Participants
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Plasma Concentration (Cmax) of MK-8189
|
700 nmol/L
Interval 405.0 to 1210.0
|
1220 nmol/L
Interval 707.0 to 2110.0
|
1270 nmol/L
Interval 738.0 to 2200.0
|
941 nmol/L
Interval 737.0 to 1200.0
|
996 nmol/L
Interval 779.0 to 1270.0
|
956 nmol/L
Interval 748.0 to 1220.0
|
1200 nmol/L
Interval 933.0 to 1540.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, and Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 1 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Tmax was determined for participants in Part 1 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=6 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=5 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=5 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=14 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
n=13 Participants
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=13 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
n=10 Participants
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time to Maximum Concentration (Tmax) of MK-8189
|
19.97 Hours
Interval 12.02 to 24.08
|
16.00 Hours
Interval 10.0 to 23.97
|
16.00 Hours
Interval 12.0 to 16.0
|
16.00 Hours
Interval 2.0 to 23.97
|
8.00 Hours
Interval 0.0 to 23.97
|
8.00 Hours
Interval 0.0 to 8.0
|
11.03 Hours
Interval 6.05 to 16.08
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 1 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
CL/F was determined for participants in Part 1 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=5 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=10 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Clearance (CL/F) of MK-8189
|
3.21 L/hr
Geometric Coefficient of Variation 36.5
|
3.22 L/hr
Geometric Coefficient of Variation 48.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 1 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
t½ was determined for participants in Part 1 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=5 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=10 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Terminal Half-life (t½) of MK-8189
|
7.99 Hours
Geometric Coefficient of Variation 15.6
|
8.68 Hours
Geometric Coefficient of Variation 26.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 1 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Vd/F was determined for participants in Part 1 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=5 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=10 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Volume of Distribution (Vd/F) of MK-8189
|
37.03 Liters
Geometric Coefficient of Variation 28.5
|
40.31 Liters
Geometric Coefficient of Variation 40.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 10, and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 2 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
AUC0-24 was determined for participants in Part 2 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=12 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=12 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=9 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=8 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
n=5 Participants
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
n=3 Participants
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
n=13 Participants
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
n=10 Participants
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
n=10 Participants
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: AUC0-24 of MK-8189
|
4600 hr*nmol/L
Interval 3210.0 to 6590.0
|
12400 hr*nmol/L
Interval 8620.0 to 17700.0
|
17100 hr*nmol/L
Interval 11400.0 to 25500.0
|
24000 hr*nmol/L
Interval 15800.0 to 36400.0
|
5930 hr*nmol/L
Interval 3800.0 to 9250.0
|
13800 hr*nmol/L
Interval 8820.0 to 21500.0
|
23600 hr*nmol/L
Interval 15100.0 to 36900.0
|
27800 hr*nmol/L
Interval 17800.0 to 43500.0
|
9860 hr*nmol/L
Interval 7810.0 to 12500.0
|
23500 hr*nmol/L
Interval 18300.0 to 30300.0
|
26800 hr*nmol/L
Interval 20600.0 to 34800.0
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 10, and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 2 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
C24 was determined for participants in Part 2 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=12 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=12 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=9 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=8 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
n=5 Participants
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
n=3 Participants
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
n=13 Participants
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
n=11 Participants
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
n=10 Participants
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: C24 of MK-8189
|
302 nmol/L
Interval 187.0 to 488.0
|
508 nmol/L
Interval 314.0 to 820.0
|
637 nmol/L
Interval 370.0 to 1100.0
|
926 nmol/L
Interval 522.0 to 1640.0
|
349 nmol/L
Interval 212.0 to 575.0
|
612 nmol/L
Interval 372.0 to 1010.0
|
927 nmol/L
Interval 563.0 to 1530.0
|
1260 nmol/L
Interval 721.0 to 2220.0
|
569 nmol/L
Interval 409.0 to 790.0
|
885 nmol/L
Interval 618.0 to 1270.0
|
1090 nmol/L
Interval 748.0 to 1590.0
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 10, and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 2 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Cmax was determined for participants in Part 2 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=12 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=12 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=9 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=8 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
n=5 Participants
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
n=3 Participants
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
n=13 Participants
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
n=12 Participants
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
n=10 Participants
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cmax of MK-8189
|
326 nmol/L
Interval 241.0 to 442.0
|
680 nmol/L
Interval 502.0 to 922.0
|
918 nmol/L
Interval 653.0 to 1290.0
|
1250 nmol/L
Interval 874.0 to 1790.0
|
373 nmol/L
Interval 235.0 to 592.0
|
817 nmol/L
Interval 514.0 to 1300.0
|
1300 nmol/L
Interval 819.0 to 2060.0
|
1330 nmol/L
Interval 837.0 to 2120.0
|
644 nmol/L
Interval 522.0 to 796.0
|
1280 nmol/L
Interval 1030.0 to 1600.0
|
1290 nmol/L
Interval 1010.0 to 1630.0
|
SECONDARY outcome
Timeframe: Days 1, 4, 7, 10, and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 2 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Tmax was determined for participants in Part 2 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=12 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=12 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=9 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
n=8 Participants
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
n=5 Participants
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
n=5 Participants
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
n=3 Participants
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
n=13 Participants
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
n=10 Participants
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
n=10 Participants
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Tmax of MK-8189
|
23.90 Hours
Interval 10.0 to 24.0
|
14.00 Hours
Interval 0.0 to 23.97
|
16.02 Hours
Interval 0.0 to 24.0
|
10.08 Hours
Interval 0.0 to 24.0
|
16.10 Hours
Interval 16.0 to 23.95
|
16.07 Hours
Interval 11.92 to 23.92
|
15.97 Hours
Interval 11.92 to 16.0
|
16.00 Hours
Interval 0.0 to 16.0
|
16.17 Hours
Interval 10.0 to 23.98
|
11.99 Hours
Interval 0.0 to 16.0
|
15.88 Hours
Interval 0.0 to 23.95
|
SECONDARY outcome
Timeframe: Days 10 and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 2 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
CL/F was determined for participants in Part 2 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=8 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=3 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=10 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: CL/F of MK-8189
|
2.67 L/hr
Geometric Coefficient of Variation 28.5
|
2.18 L/hr
Geometric Coefficient of Variation 57.3
|
2.34 L/hr
Geometric Coefficient of Variation 29.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 10 and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 2 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
t½ was determined for participants in Part 2 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=6 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=3 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=10 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: t½ of MK-8189
|
13.98 Hours
Geometric Coefficient of Variation 51.0
|
8.90 Hours
Geometric Coefficient of Variation 33.4
|
9.99 Hours
Geometric Coefficient of Variation 27.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 10 and 13: Predose and 2, 6, 8, 10, 12, 16, and 24 hours postdosePopulation: Part 2 participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Vd/F was determined for participants in Part 2 panels who received MK-8189.
Outcome measures
| Measure |
Part 1, Panel A: MK-8189 16 mg to 24 mg
n=6 Participants
Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg (Days 1 to 3) to 24 mg (Days 4 to 7) QD for 7 days.
|
Part 1, Panel B: MK-8189 24 mg
n=3 Participants
Young adult participants with schizophrenia receive MK-8189 24 mg QD from Day 1 to Day 7.
|
Part 1, Panel C: MK-8189 8 mg t0 24 mg
n=10 Participants
Young adult participants with schizophrenia were planned to receive MK-8189 titrated from 8 mg to 24 mg QD over 7 days.
|
Part 2, Panel D: MK-8189 8 mg to 24 mg
Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel E: MK-8189 16 mg to 24 mg
Elderly adult participants with schizophrenia were intended to receive MK-8189 titrated from 16 mg to 24 mg QD, over 10 days.
|
Part 2, Panel F: MK-8189 8 mg to 24 mg
Healthy elderly adult participants receive receive MK-8189 titrated from 8 mg (Days 1 to 3), to 16 mg (Days 4 to 7), to 24 mg (Days 7 to 13) QD over 13 days.
|
Part 2, Panel G: MK-8189 16 mg to 24 mg
Healthy elderly adult participants receive MK-8189 titrated from 16 mg (Days 1 to 3), to 24 mg (Days 4 to 10) QD over 10 days.
|
Part 1: Placebo
Young adult participants with schizophrenia receive placebo matched to MK-8189 QD for 7 days.
|
Part 2: Placebo
Elderly participants with schizophrenia and heathy elderly participants receive placebo matched to MK-8189 for up to 13 days.
|
Part 2, Panel G: MK-8189 24 mg
The PK of MK-8189 24 mg was assessed on Day 4 in Panel G.
|
Part 2, Panel G: MK-8189 24 mg Day 10
The PK of MK-8189 24 mg was assessed on Day 10 in Panel G.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Vd/F of MK-8189
|
55.23 Liters
Geometric Coefficient of Variation 52.3
|
27.94 Liters
Geometric Coefficient of Variation 57.2
|
32.91 Liters
Geometric Coefficient of Variation 26.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
MK-8189 8 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-8189 16 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
MK-8189 24 mg
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-8189 Total
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Total Participants
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-8189 8 mg
n=17 participants at risk
All participants who received MK-8189 8 mg are included.
|
MK-8189 16 mg
n=36 participants at risk
All participants who received MK-8189 16 mg are included.
|
MK-8189 24 mg
n=45 participants at risk
All participants who received MK-8189 24 mg are included.
|
Placebo
n=13 participants at risk
All participants who received placebo are included.
|
MK-8189 Total
n=50 participants at risk
All participants in Parts 1 and 2 who received any dose of MK-8189 are included.
|
Total Participants
n=63 participants at risk
All study participants in Parts 1 and 2 are included.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/63 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
8.3%
3/36 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.0%
3/50 • Number of events 4 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.8%
3/63 • Number of events 4 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.4%
2/45 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.0%
3/50 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.8%
3/63 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/63 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.7%
3/45 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.0%
3/50 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.8%
3/63 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
5.6%
2/36 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.0%
2/50 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
11.1%
5/45 • Number of events 6 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
10.0%
5/50 • Number of events 6 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.9%
5/63 • Number of events 6 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
General disorders
Fatigue
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Investigations
Liver function test increased
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/63 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
2/17 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.4%
2/45 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
10.0%
5/50 • Number of events 5 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
9.5%
6/63 • Number of events 6 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.0%
2/50 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.4%
2/45 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.0%
3/50 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.8%
3/63 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.0%
2/50 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Akathisia
|
5.9%
1/17 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
5.6%
2/36 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
8.0%
4/50 • Number of events 4 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.3%
4/63 • Number of events 4 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Dystonia
|
5.9%
1/17 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
5.6%
2/36 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.0%
3/50 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.3%
4/63 • Number of events 4 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.7%
3/45 • Number of events 4 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.0%
3/50 • Number of events 4 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.3%
4/63 • Number of events 6 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.7%
3/45 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.0%
3/50 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.3%
4/63 • Number of events 4 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
5.6%
2/36 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.0%
2/50 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Oromandibular dystonia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.0%
2/50 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
19.4%
7/36 • Number of events 7 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.7%
3/45 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
22.0%
11/50 • Number of events 11 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
19.0%
12/63 • Number of events 12 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.7%
3/45 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.0%
3/50 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.8%
3/63 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.0%
2/50 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Psychiatric disorders
Hallucination, tactile
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/63 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Psychiatric disorders
Hypnagogic hallucination
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.4%
2/45 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.0%
2/50 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
3.2%
2/63 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Psychiatric disorders
Restlessness
|
5.9%
1/17 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
5.6%
2/36 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
6.0%
3/50 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
4.8%
3/63 • Number of events 3 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/63 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 2 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.8%
1/36 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.2%
1/45 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/13 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
2.0%
1/50 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/17 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/36 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/45 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
7.7%
1/13 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
0.00%
0/50 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
1.6%
1/63 • Number of events 1 • Up to approximately 27 days
All randomized participants received ≥1 dose of study therapy and are included in all cause mortality and safety assessment.
|
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