Trial Outcomes & Findings for A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate (NCT NCT03488719)
NCT ID: NCT03488719
Last Updated: 2024-02-09
Results Overview
The dose of metoprolol which resulted in no change relative to baseline in mean heart rate over 24 hours (M24HR) for each respective dose of tesofensine was calculated from a dose response relationship with the log-dose of metoprolol as independent variable and change in M24HR induced by various doses of metoprolol given to subjects on steady-state dose of tesofensine as the dependent variable. The dose for no change in M24HR derived from above calculation and the corresponding 95% confidence interval (CI) is presented for each dose of tesofensine. The result in this endpoint is not an arithmetic mean, but the model derived estimated dose from the model. Mitigating dose was estimated using a linear regression modelling mean change from pre-tesofensine baseline (Day -1) of M24HR as a function of the log metoprolol dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Day -1 to Day 23
Results posted on
2024-02-09
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Tesofensine 0.25mg)
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
16
|
12
|
|
Overall Study
Metoprolol 25 mg
|
9
|
13
|
5
|
|
Overall Study
Metoprolol 50 mg
|
9
|
13
|
6
|
|
Overall Study
Metoprolol 100 mg
|
9
|
13
|
5
|
|
Overall Study
COMPLETED
|
9
|
12
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
7
|
Reasons for withdrawal
| Measure |
Cohort 1 (Tesofensine 0.25mg)
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
2
|
|
Overall Study
Other
|
0
|
0
|
5
|
Baseline Characteristics
A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate
Baseline characteristics by cohort
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=16 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=12 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 11.61 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 10.55 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
37 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Height
|
174.1 cm
STANDARD_DEVIATION 10.91 • n=5 Participants
|
171.1 cm
STANDARD_DEVIATION 9.84 • n=7 Participants
|
170.1 cm
STANDARD_DEVIATION 6.49 • n=5 Participants
|
171.5 cm
STANDARD_DEVIATION 9.06 • n=4 Participants
|
|
Weight
|
95.52 kg
STANDARD_DEVIATION 11.602 • n=5 Participants
|
88.56 kg
STANDARD_DEVIATION 9.801 • n=7 Participants
|
91.08 kg
STANDARD_DEVIATION 10.925 • n=5 Participants
|
91.07 kg
STANDARD_DEVIATION 10.685 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day -1 to Day 23Population: Pharmacodynamic (PD) Population: All randomized subjects with at least HR assessments (24 Hour Holter) on Baseline (Day -2 to -1) and on at least 2 Visits out of, Day 15, Day 18 and Day 21 without any major protocol deviations which could have influenced the PD parameters.
The dose of metoprolol which resulted in no change relative to baseline in mean heart rate over 24 hours (M24HR) for each respective dose of tesofensine was calculated from a dose response relationship with the log-dose of metoprolol as independent variable and change in M24HR induced by various doses of metoprolol given to subjects on steady-state dose of tesofensine as the dependent variable. The dose for no change in M24HR derived from above calculation and the corresponding 95% confidence interval (CI) is presented for each dose of tesofensine. The result in this endpoint is not an arithmetic mean, but the model derived estimated dose from the model. Mitigating dose was estimated using a linear regression modelling mean change from pre-tesofensine baseline (Day -1) of M24HR as a function of the log metoprolol dose.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Dose of Metoprolol Resulting in no Change in Mean Heart Rate Over 24 Hours (M24HR)
|
10.04 mg
Interval 0.01 to 34.26
|
60.95 mg
Interval 35.27 to 99.43
|
147.91 mg
Interval 61.28 to 362.29
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 14, 17, 20 and 23Population: Pharmacodynamic population required heart rate (HR) at baseline and at least 2 visits out of Day 15, Day 18, Day 21, thus subjects discontinued before Day 18 were excluded. The number of participants listed below is the number of subjects with an assessment at the specified time point.
M24HR at Baseline (Day -1) and Days 14, 17, 20 and 23.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23
Baseline
|
73.4 bpm
Standard Deviation 8.47
|
73.1 bpm
Standard Deviation 5.48
|
74.3 bpm
Standard Deviation 5.82
|
|
Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23
Day 14
|
72.6 bpm
Standard Deviation 8.17
|
76.5 bpm
Standard Deviation 6.98
|
81.3 bpm
Standard Deviation 4.97
|
|
Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23
Day 17
|
75.1 bpm
Standard Deviation 10.93
|
78.2 bpm
Standard Deviation 5.85
|
84.7 bpm
Standard Deviation 8.31
|
|
Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23
Day 20
|
75.7 bpm
Standard Deviation 9.33
|
80.9 bpm
Standard Deviation 5.84
|
83.2 bpm
Standard Deviation 7.98
|
|
Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23
Day 23
|
78.8 bpm
Standard Deviation 10.41
|
84.3 bpm
Standard Deviation 8.59
|
85.4 bpm
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: Days 15, 18, or 21Population: Pharmacodynamic population required heart rate (HR) at baseline and at least 2 visits out of Day 15, Day 18, Day 21, thus subjects discontinued before Day 18 were excluded. The number of participants listed below is the number of subjects with an assessment at the specified time point.
M24HR following each of the 3 metoprolol doses (M24HR on Days 15, 18 or 21).
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21
Metoprolol 25 mg
|
71.1 bpm
Standard Deviation 9.45
|
76.5 bpm
Standard Deviation 7.68
|
80.0 bpm
Standard Deviation 7.71
|
|
Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21
Metoprolol 50 mg
|
69.6 bpm
Standard Deviation 9.40
|
73.9 bpm
Standard Deviation 5.75
|
80.8 bpm
Standard Deviation 7.83
|
|
Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21
Metoprolol 100 mg
|
69.2 bpm
Standard Deviation 9.46
|
70.7 bpm
Standard Deviation 6.05
|
73.6 bpm
Standard Deviation 3.91
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 14, Day 17, Day 20, Day 23Population: Pharmacodynamic population required heart rate (HR) at baseline and at least 2 visits out of Day 15, Day 18, Day 21, thus subjects discontinued before Day 18 were excluded. The number of participants listed below is the number of subjects with an assessment at the specified time point.
Change in M24HR between pre-tesofensine baseline (Day -1) and after tesofensine alone (Day 14, Day 17, Day 20 and Day 23)
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Change in Mean Heart Rate Over 24 Hours (M24HR) Between Pre-tesofensine Baseline (Day -1) and After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
Change at Day 14
|
-0.9 bpm
Standard Deviation 2.20
|
3.5 bpm
Standard Deviation 4.50
|
7.0 bpm
Standard Deviation 5.69
|
|
Change in Mean Heart Rate Over 24 Hours (M24HR) Between Pre-tesofensine Baseline (Day -1) and After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
Change at Day 17
|
1.7 bpm
Standard Deviation 5.32
|
5.2 bpm
Standard Deviation 4.56
|
10.3 bpm
Standard Deviation 6.44
|
|
Change in Mean Heart Rate Over 24 Hours (M24HR) Between Pre-tesofensine Baseline (Day -1) and After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
Change at Day 20
|
2.2 bpm
Standard Deviation 3.31
|
7.8 bpm
Standard Deviation 3.21
|
10.0 bpm
Standard Deviation 6.48
|
|
Change in Mean Heart Rate Over 24 Hours (M24HR) Between Pre-tesofensine Baseline (Day -1) and After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
Change at Day 23
|
5.3 bpm
Standard Deviation 5.34
|
11.8 bpm
Standard Deviation 6.62
|
12.2 bpm
Standard Deviation 6.83
|
SECONDARY outcome
Timeframe: Day 15, Day 18, Day 21Population: Pharmacodynamic population required heart rate (HR) at baseline and at least 2 visits out of Day 15, Day 18, Day 21, thus subjects discontinued before Day 18 were excluded. The number of participants listed below is the number of subjects with an assessment at the specified time point.
Change in M24HR values after tesofensine co-administered with metoprolol. As the three metoprolol doses were given in a random order these results are not reported as Day 15, Day 18 and Day 21 but instead as change from matched day.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol
Metoprolol 25 mg
|
2.7 bpm
Standard Deviation 2.87
|
-2.9 bpm
Standard Deviation 2.25
|
-2.2 bpm
Standard Deviation 2.05
|
|
Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol
Metoprolol 50 mg
|
-4.8 bpm
Standard Deviation 2.77
|
-4.8 bpm
Standard Deviation 2.89
|
-4.7 bpm
Standard Deviation 2.42
|
|
Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol
Metoprolol 100 mg
|
-6.0 bpm
Standard Deviation 3.50
|
-6.9 bpm
Standard Deviation 2.50
|
-7.6 bpm
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Day 14, Day 17, Day 20 and Day 23Population: Pharmacodynamic population required heart rate (HR) at baseline and at least 2 visits out of Day 15, Day 18, Day 21, thus subjects discontinued before Day 18 were excluded. The number of participants listed below is the number of subjects with an assessment at the specified time point.
Maximum and minimum heart rate of 24 hours (HRmax and HRmin) values after tesofensine alone (Day 14, Day 17, Day 20 and Day 23)
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
HRmax Day 14
|
114.4 bpm
Standard Deviation 11.53
|
117.5 bpm
Standard Deviation 10.43
|
124.2 bpm
Standard Deviation 17.79
|
|
Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
HRmax Day 17
|
119.2 bpm
Standard Deviation 19.47
|
124.6 bpm
Standard Deviation 11.57
|
126.2 bpm
Standard Deviation 17.63
|
|
Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
HRmax Day 20;
|
117.0 bpm
Standard Deviation 18.83
|
125.2 bpm
Standard Deviation 12.21
|
131.0 bpm
Standard Deviation 20.36
|
|
Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
HRmax Day 23
|
125.6 bpm
Standard Deviation 10.19
|
134.5 bpm
Standard Deviation 12.77
|
133.6 bpm
Standard Deviation 17.97
|
|
Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
HRmin Day 14
|
54.2 bpm
Standard Deviation 6.51
|
56.7 bpm
Standard Deviation 5.78
|
59.5 bpm
Standard Deviation 4.42
|
|
Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
HRmin Day 17
|
54.1 bpm
Standard Deviation 7.11
|
58.5 bpm
Standard Deviation 4.86
|
60.2 bpm
Standard Deviation 6.74
|
|
Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
HRmin Day 20
|
55.0 bpm
Standard Deviation 6.36
|
58.9 bpm
Standard Deviation 5.53
|
60.6 bpm
Standard Deviation 6.95
|
|
Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
HRmin Day 23
|
56.8 bpm
Standard Deviation 7.60
|
59.7 bpm
Standard Deviation 5.69
|
61.6 bpm
Standard Deviation 6.11
|
SECONDARY outcome
Timeframe: Day 15, Day 18, Day 21Population: Pharmacodynamic population required heart rate (HR) at baseline and at least 2 visits out of Day 15, Day 18, Day 21, thus subjects discontinued before Day 18 were excluded. The number of participants listed below is the number of subjects with an assessment at given time point.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Maximum Heart Rate (HRmax) and Minimum Heart Rate (HRmin) Values After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Metoprolol 25 mg; HR max
|
107.3 bpm
Standard Deviation 11.93
|
117.8 bpm
Standard Deviation 14.32
|
120.0 bpm
Standard Deviation 11.73
|
|
Maximum Heart Rate (HRmax) and Minimum Heart Rate (HRmin) Values After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Metoprolol 25 mg; HR min
|
53.7 bpm
Standard Deviation 8.06
|
56.7 bpm
Standard Deviation 5.89
|
57.4 bpm
Standard Deviation 3.51
|
|
Maximum Heart Rate (HRmax) and Minimum Heart Rate (HRmin) Values After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Metoprolol 50 mg; HR max
|
113.2 bpm
Standard Deviation 19.90
|
118.5 bpm
Standard Deviation 10.24
|
125.0 bpm
Standard Deviation 14.14
|
|
Maximum Heart Rate (HRmax) and Minimum Heart Rate (HRmin) Values After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Metoprolol 50 mg; HR min
|
51.9 bpm
Standard Deviation 6.09
|
55.9 bpm
Standard Deviation 4.65
|
55.7 bpm
Standard Deviation 5.43
|
|
Maximum Heart Rate (HRmax) and Minimum Heart Rate (HRmin) Values After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Metoprolol 100 mg; HR max
|
112.7 bpm
Standard Deviation 19.89
|
111.9 bpm
Standard Deviation 9.42
|
114.0 bpm
Standard Deviation 12.27
|
|
Maximum Heart Rate (HRmax) and Minimum Heart Rate (HRmin) Values After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Metoprolol 100 mg; HR min
|
51.7 bpm
Standard Deviation 7.68
|
52.9 bpm
Standard Deviation 4.66
|
55.6 bpm
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: From 12 to 13 hours post-dose on Day 14, Day 17, Day 20 and Day 23Population: Pharmacodynamic population required heart rate (HR) at baseline and at least 2 visits out of Day 15, Day 18, Day 21, thus subjects discontinued before Day 18 were excluded. The number of participants listed below is the number of subjects with an assessment at the specified time point.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Mean Heart Rate (HR) During a Designated Quiet Hour and a Designated Period After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
Day 14
|
70.0 bpm
Standard Deviation 9.99
|
71.4 bpm
Standard Deviation 9.52
|
77.8 bpm
Standard Deviation 10.50
|
|
Mean Heart Rate (HR) During a Designated Quiet Hour and a Designated Period After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
Day 17
|
73.4 bpm
Standard Deviation 12.57
|
72.9 bpm
Standard Deviation 7.45
|
80.3 bpm
Standard Deviation 11.48
|
|
Mean Heart Rate (HR) During a Designated Quiet Hour and a Designated Period After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
Day 20
|
73.0 bpm
Standard Deviation 11.15
|
75.8 bpm
Standard Deviation 8.33
|
77.8 bpm
Standard Deviation 8.38
|
|
Mean Heart Rate (HR) During a Designated Quiet Hour and a Designated Period After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
Day 23
|
75.7 bpm
Standard Deviation 12.24
|
76.8 bpm
Standard Deviation 10.63
|
77.8 bpm
Standard Deviation 7.40
|
SECONDARY outcome
Timeframe: From 12 to 13 hours post-dose on Day 15, Day 18, or Day 21Population: Pharmacodynamic population required heart rate (HR) at baseline and at least 2 visits out of Day 15, Day 18, Day 21, thus subjects discontinued before Day 18 were excluded. The number of participants listed below is the number of subjects with an assessment at given time point.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Mean Heart Rate (HR) During a Designated Quiet Hour and a Designated Period After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Metoprolol 25 mg
|
66.8 bpm
Standard Deviation 11.45
|
70.5 bpm
Standard Deviation 8.75
|
77.6 bpm
Standard Deviation 9.21
|
|
Mean Heart Rate (HR) During a Designated Quiet Hour and a Designated Period After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Metoprolol 50 mg
|
65.7 bpm
Standard Deviation 10.20
|
68.8 bpm
Standard Deviation 7.91
|
74.2 bpm
Standard Deviation 10.19
|
|
Mean Heart Rate (HR) During a Designated Quiet Hour and a Designated Period After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Metoprolol 100 mg
|
65.4 bpm
Standard Deviation 10.99
|
65.6 bpm
Standard Deviation 8.14
|
68.4 bpm
Standard Deviation 7.33
|
SECONDARY outcome
Timeframe: Day -1, Day 13 [pre-dose only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23Population: All subjects included in the study and dosed with investigational medicinal product (IMP) were included in the safety population. The number of participants listed below is the number of subjects with an assessment at the specified time point.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=16 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=12 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/2h postdose (metop. 100 mg)
|
69.14 bpm
Standard Deviation 14.391
|
69.66 bpm
Standard Deviation 11.330
|
63.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/4h postdose (metop. 100 mg)
|
70.0 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
61.00 bpm
Standard Deviation 8.061
|
66.10 bpm
Standard Deviation 10.198
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/8h postdose (metop. 100 mg)
|
72.30 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
58.35 bpm
Standard Deviation 8.980
|
65.23 bpm
Standard Deviation 3.233
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/12h postdose (metop. 100 mg)
|
77.30 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
62.30 bpm
Standard Deviation 2.828
|
71.33 bpm
Standard Deviation 9.292
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/predose (metop. 100 mg)
|
64.60 bpm
Standard Deviation 11.603
|
67.08 bpm
Standard Deviation 8.499
|
76.00 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/4h postdose (metop. 100 mg)
|
60.12 bpm
Standard Deviation 11.471
|
60.66 bpm
Standard Deviation 9.142
|
56.00 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/8h postdose (metop. 100 mg)
|
59.72 bpm
Standard Deviation 11.113
|
61.66 bpm
Standard Deviation 11.039
|
56.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/12h postdose (metop. 100 mg)
|
65.34 bpm
Standard Deviation 13.190
|
68.06 bpm
Standard Deviation 9.870
|
71.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 23/12h postdose
|
75.03 bpm
Standard Deviation 12.274
|
77.75 bpm
Standard Deviation 10.730
|
82.00 bpm
Standard Deviation 9.300
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/predose (metop. 25 mg)
|
64.03 bpm
Standard Deviation 7.024
|
59.48 bpm
Standard Deviation 2.873
|
73.67 bpm
Standard Deviation 5.677
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day -1/predose
|
62.11 bpm
Standard Deviation 6.579
|
63.14 bpm
Standard Deviation 7.703
|
65.71 bpm
Standard Deviation 7.051
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day -1/2h postdose
|
70.03 bpm
Standard Deviation 7.317
|
71.65 bpm
Standard Deviation 8.236
|
70.18 bpm
Standard Deviation 9.287
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day -1/4h postdose
|
65.60 bpm
Standard Deviation 8.408
|
65.71 bpm
Standard Deviation 8.705
|
66.87 bpm
Standard Deviation 8.109
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day -1/8h postdose
|
64.26 bpm
Standard Deviation 7.590
|
65.38 bpm
Standard Deviation 7.077
|
65.93 bpm
Standard Deviation 7.195
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day -1/12h postdose
|
72.13 bpm
Standard Deviation 10.416
|
68.17 bpm
Standard Deviation 6.511
|
71.08 bpm
Standard Deviation 9.917
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 13/predose
|
64.89 bpm
Standard Deviation 6.680
|
71.48 bpm
Standard Deviation 8.783
|
74.11 bpm
Standard Deviation 7.645
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 14/predose
|
62.41 bpm
Standard Deviation 6.929
|
63.98 bpm
Standard Deviation 6.973
|
70.01 bpm
Standard Deviation 7.574
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 14/2h postdose
|
66.00 bpm
Standard Deviation 9.106
|
70.11 bpm
Standard Deviation 8.787
|
72.53 bpm
Standard Deviation 8.269
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 14/4h postdose
|
62.81 bpm
Standard Deviation 7.803
|
69.03 bpm
Standard Deviation 9.568
|
72.03 bpm
Standard Deviation 9.966
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 14/8h postdose
|
64.57 bpm
Standard Deviation 8.509
|
69.76 bpm
Standard Deviation 9.156
|
73.49 bpm
Standard Deviation 7.267
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 14/12h postdose
|
70.19 bpm
Standard Deviation 10.114
|
72.65 bpm
Standard Deviation 9.286
|
80.17 bpm
Standard Deviation 9.304
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 17/predose
|
63.94 bpm
Standard Deviation 8.928
|
67.46 bpm
Standard Deviation 7.148
|
72.49 bpm
Standard Deviation 6.267
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 17/2h postdose
|
69.37 bpm
Standard Deviation 13.141
|
71.81 bpm
Standard Deviation 7.052
|
79.18 bpm
Standard Deviation 10.040
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 17/4h postdose
|
65.22 bpm
Standard Deviation 11.339
|
67.85 bpm
Standard Deviation 6.367
|
72.80 bpm
Standard Deviation 8.155
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 17/8h postdose
|
65.33 bpm
Standard Deviation 10.546
|
69.58 bpm
Standard Deviation 9.254
|
75.43 bpm
Standard Deviation 6.394
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 17/12h postdose
|
72.99 bpm
Standard Deviation 13.349
|
73.61 bpm
Standard Deviation 6.739
|
84.45 bpm
Standard Deviation 13.229
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 20/predose
|
65.01 bpm
Standard Deviation 8.519
|
67.86 bpm
Standard Deviation 7.128
|
75.48 bpm
Standard Deviation 12.388
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 20/2h postdose
|
71.04 bpm
Standard Deviation 11.835
|
75.92 bpm
Standard Deviation 7.602
|
77.66 bpm
Standard Deviation 9.390
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 20/4h postdose
|
65.81 bpm
Standard Deviation 9.536
|
71.79 bpm
Standard Deviation 8.061
|
73.86 bpm
Standard Deviation 9.380
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 20/8h postdose
|
64.78 bpm
Standard Deviation 8.599
|
71.41 bpm
Standard Deviation 7.260
|
74.08 bpm
Standard Deviation 10.559
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 20/12h postdose
|
72.33 bpm
Standard Deviation 11.407
|
76.69 bpm
Standard Deviation 8.385
|
81.60 bpm
Standard Deviation 12.056
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 23/predose
|
63.14 bpm
Standard Deviation 10.228
|
71.69 bpm
Standard Deviation 11.467
|
75.68 bpm
Standard Deviation 8.004
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 23/2h postdose
|
71.97 bpm
Standard Deviation 14.111
|
77.33 bpm
Standard Deviation 8.980
|
78.92 bpm
Standard Deviation 5.821
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 23/4h postdose
|
68.33 bpm
Standard Deviation 14.452
|
73.53 bpm
Standard Deviation 12.354
|
73.90 bpm
Standard Deviation 8.044
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 23/8h postdose
|
68.04 bpm
Standard Deviation 14.294
|
73.88 bpm
Standard Deviation 10.252
|
74.28 bpm
Standard Deviation 4.754
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/2h postdose (metop. 25 mg)
|
72.13 bpm
Standard Deviation 13.967
|
63.18 bpm
Standard Deviation 3.767
|
78.77 bpm
Standard Deviation 3.044
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/4h postdose (metop. 25 mg)
|
63.87 bpm
Standard Deviation 11.356
|
55.73 bpm
Standard Deviation 4.057
|
71.90 bpm
Standard Deviation 3.483
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/8h postdose (metop. 25 mg)
|
63.67 bpm
Standard Deviation 11.257
|
58.23 bpm
Standard Deviation 1.776
|
73.10 bpm
Standard Deviation 7.045
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/12h postdose (metop. 25 mg)
|
64.23 bpm
Standard Deviation 15.989
|
60.85 bpm
Standard Deviation 4.615
|
79.53 bpm
Standard Deviation 7.012
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/predose (metop. 25 mg)
|
62.28 bpm
Standard Deviation 7.486
|
71.40 bpm
Standard Deviation 9.612
|
97.20 bpm
Standard Deviation 27.577
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/2h postdose (metop. 25 mg)
|
65.82 bpm
Standard Deviation 7.663
|
71.78 bpm
Standard Deviation 4.462
|
83.65 bpm
Standard Deviation 10.819
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/4h postdose (metop. 25 mg)
|
57.72 bpm
Standard Deviation 4.800
|
69.40 bpm
Standard Deviation 6.557
|
80.50 bpm
Standard Deviation 14.425
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/8h postdose (metop. 25 mg)
|
59.34 bpm
Standard Deviation 4.298
|
73.14 bpm
Standard Deviation 8.564
|
82.85 bpm
Standard Deviation 12.516
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/12h postdose (metop. 25 mg)
|
62.34 bpm
Standard Deviation 5.816
|
76.80 bpm
Standard Deviation 8.243
|
87.00 bpm
Standard Deviation 6.081
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/predose (metop. 25 mg)
|
73.30 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
76.90 bpm
Standard Deviation 3.344
|
72.00 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/2h postdose (metop. 25 mg)
|
75.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
80.00 bpm
Standard Deviation 5.170
|
68.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/4h postdose (metop. 25 mg)
|
77.00 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
73.23 bpm
Standard Deviation 2.165
|
70.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/8h postdose (metop. 25 mg)
|
72.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
71.40 bpm
Standard Deviation 4.723
|
64.00 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/12h postdose (metop. 25 mg)
|
80.0 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
74.23 bpm
Standard Deviation 3.015
|
74.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/predose (metop. 50 mg)
|
61.43 bpm
Standard Deviation 10.112
|
70.47 bpm
Standard Deviation 6.353
|
74.85 bpm
Standard Deviation 0.212
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/2h postdose (metop. 50 mg)
|
65.10 bpm
Standard Deviation 9.986
|
74.00 bpm
Standard Deviation 5.568
|
75.15 bpm
Standard Deviation 6.859
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/4h postdose (metop. 50 mg)
|
60.43 bpm
Standard Deviation 10.327
|
67.47 bpm
Standard Deviation 4.895
|
70.85 bpm
Standard Deviation 0.212
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/8h postdose (metop. 50 mg)
|
59.67 bpm
Standard Deviation 9.205
|
69.10 bpm
Standard Deviation 7.136
|
66.70 bpm
Standard Deviation 1.414
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/12h postdose (metop. 50 mg)
|
65.00 bpm
Standard Deviation 9.853
|
74.33 bpm
Standard Deviation 3.953
|
71.20 bpm
Standard Deviation 4.950
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/predose (metop. 50 mg)
|
66.00 bpm
Standard Deviation 13.454
|
67.17 bpm
Standard Deviation 7.909
|
88.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/2h postdose (metop. 50 mg)
|
72.13 bpm
Standard Deviation 16.783
|
71.72 bpm
Standard Deviation 7.843
|
100.00 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/4h postdose (metop. 50 mg)
|
62.57 bpm
Standard Deviation 12.307
|
64.50 bpm
Standard Deviation 7.223
|
90.30 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/8h postdose (metop. 50 mg)
|
63.10 bpm
Standard Deviation 14.509
|
61.88 bpm
Standard Deviation 6.462
|
79.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/12h postdose (metop. 50 mg)
|
65.70 bpm
Standard Deviation 14.526
|
64.38 bpm
Standard Deviation 6.019
|
86.30 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/predose (metop. 50 mg)
|
63.53 bpm
Standard Deviation 2.658
|
65.25 bpm
Standard Deviation 7.722
|
81.67 bpm
Standard Deviation 16.359
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/2h postdose (metop. 50 mg)
|
64.90 bpm
Standard Deviation 5.188
|
71.33 bpm
Standard Deviation 13.126
|
79.20 bpm
Standard Deviation 10.613
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/4h postdose (metop. 50 mg)
|
60.90 bpm
Standard Deviation 9.106
|
64.75 bpm
Standard Deviation 8.048
|
71.67 bpm
Standard Deviation 10.855
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/8h postdose (metop. 50 mg)
|
61.97 bpm
Standard Deviation 15.144
|
62.83 bpm
Standard Deviation 6.737
|
74.33 bpm
Standard Deviation 6.987
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 21/12h postdose (metop. 50 mg)
|
61.33 bpm
Standard Deviation 4.384
|
67.00 bpm
Standard Deviation 8.922
|
78.13 bpm
Standard Deviation 8.790
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/predose (metop. 100 mg)
|
70.00 bpm
Standard Deviation 6.324
|
68.83 bpm
Standard Deviation 5.611
|
79.50 bpm
Standard Deviation 17.253
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/2h postdose (metop. 100 mg)
|
60.70 bpm
Standard Deviation 3.000
|
68.28 bpm
Standard Deviation 3.520
|
68.15 bpm
Standard Deviation 8.697
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/4h postdose (metop. 100 mg)
|
54.53 bpm
Standard Deviation 1.079
|
59.97 bpm
Standard Deviation 3.989
|
65.80 bpm
Standard Deviation 7.778
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/8h postdose (metop. 100 mg)
|
56.57 bpm
Standard Deviation 6.772
|
61.88 bpm
Standard Deviation 10.818
|
65.15 bpm
Standard Deviation 6.859
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 15/12h postdose (metop. 100 mg)
|
56.57 bpm
Standard Deviation 0.513
|
65.18 bpm
Standard Deviation 6.649
|
71.50 bpm
Standard Deviation 10.182
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/predose (metop. 100 mg)
|
72.00 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
68.35 bpm
Standard Deviation 10.394
|
73.74 bpm
Standard Deviation 3.356
|
|
Heart Rate (HR) After at Least 10 Minutes Rest Before Each Pharmacokinetic (PK) Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23)
Day 18/2h postdose (metop. 100 mg)
|
76.70 bpm
Standard Deviation NA
NA=not calculated/1 subject
|
65.65 bpm
Standard Deviation 9.405
|
74.33 bpm
Standard Deviation 8.736
|
SECONDARY outcome
Timeframe: Day -1, Day 13 [pre-dose only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23Population: All subjects included in the study and dosed with IMP were included in the safety population. The number of participants listed below is the number of subjects with an assessment at the specified time point.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=16 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=12 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/predose (metop. 50 mg)
|
80.47 mm Hg
Standard Deviation 8.495
|
71.83 mm Hg
Standard Deviation 5.043
|
80.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/4h postdose (metop. 100 mg)
|
68.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
76.00 mm Hg
Standard Deviation 4.667
|
75.57 mm Hg
Standard Deviation 5.353
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/2h postdose (metop. 50 mg)
|
117.57 mm Hg
Standard Deviation 9.416
|
108.90 mm Hg
Standard Deviation 11.661
|
117.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day -1/predose
|
73.09 mm Hg
Standard Deviation 8.953
|
71.00 mm Hg
Standard Deviation 5.235
|
73.83 mm Hg
Standard Deviation 5.838
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day -1/2h postdose
|
67.07 mm Hg
Standard Deviation 7.998
|
63.87 mm Hg
Standard Deviation 7.387
|
69.66 mm Hg
Standard Deviation 5.233
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day -1/4h postdose
|
70.26 mm Hg
Standard Deviation 9.593
|
68.68 mm Hg
Standard Deviation 4.609
|
71.86 mm Hg
Standard Deviation 5.184
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day -1/8h postdose
|
72.11 mm Hg
Standard Deviation 9.712
|
69.39 mm Hg
Standard Deviation 5.265
|
74.88 mm Hg
Standard Deviation 5.346
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/12h postdose (metop. 50 mg)
|
70.00 mm Hg
Standard Deviation 7.550
|
74.20 mm Hg
Standard Deviation 6.183
|
69.50 mm Hg
Standard Deviation 1.131
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day -1/12h postdose
|
68.91 mm Hg
Standard Deviation 9.942
|
66.66 mm Hg
Standard Deviation 5.051
|
71.27 mm Hg
Standard Deviation 6.221
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 13/predose
|
70.48 mm Hg
Standard Deviation 10.740
|
71.24 mm Hg
Standard Deviation 5.017
|
77.79 mm Hg
Standard Deviation 7.288
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 14/predose
|
71.16 mm Hg
Standard Deviation 10.810
|
71.58 mm Hg
Standard Deviation 6.727
|
77.73 mm Hg
Standard Deviation 5.384
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 14/2h postdose
|
68.94 mm Hg
Standard Deviation 9.394
|
67.23 mm Hg
Standard Deviation 5.930
|
75.13 mm Hg
Standard Deviation 7.129
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 14/4h postdose
|
71.00 mm Hg
Standard Deviation 8.895
|
70.19 mm Hg
Standard Deviation 5.499
|
77.54 mm Hg
Standard Deviation 7.374
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 14/8h postdose
|
74.08 mm Hg
Standard Deviation 10.285
|
72.23 mm Hg
Standard Deviation 6.881
|
77.49 mm Hg
Standard Deviation 4.556
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 14/12h postdose
|
73.12 mm Hg
Standard Deviation 8.227
|
70.08 mm Hg
Standard Deviation 6.681
|
76.69 mm Hg
Standard Deviation 5.087
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 17/predose
|
70.68 mm Hg
Standard Deviation 9.731
|
70.76 mm Hg
Standard Deviation 4.939
|
75.90 mm Hg
Standard Deviation 5.160
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 17/2h postdose
|
68.70 mm Hg
Standard Deviation 10.010
|
67.91 mm Hg
Standard Deviation 5.120
|
75.83 mm Hg
Standard Deviation 5.199
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 17/4h postdose
|
70.11 mm Hg
Standard Deviation 9.157
|
70.75 mm Hg
Standard Deviation 5.893
|
78.65 mm Hg
Standard Deviation 8.054
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 17/8h postdose
|
70.96 mm Hg
Standard Deviation 9.215
|
70.97 mm Hg
Standard Deviation 7.122
|
81.38 mm Hg
Standard Deviation 7.746
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 17/12h postdose
|
70.89 mm Hg
Standard Deviation 9.080
|
70.15 mm Hg
Standard Deviation 6.363
|
78.38 mm Hg
Standard Deviation 8.679
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 20/predose
|
71.12 mm Hg
Standard Deviation 10.779
|
68.89 mm Hg
Standard Deviation 6.413
|
75.08 mm Hg
Standard Deviation 9.153
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 20/2h postdose
|
68.70 mm Hg
Standard Deviation 7.133
|
67.54 mm Hg
Standard Deviation 4.643
|
75.48 mm Hg
Standard Deviation 11.316
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 20/4h postdose
|
69.88 mm Hg
Standard Deviation 8.037
|
69.85 mm Hg
Standard Deviation 5.340
|
78.08 mm Hg
Standard Deviation 7.286
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 20/8h postdose
|
72.27 mm Hg
Standard Deviation 8.309
|
71.18 mm Hg
Standard Deviation 6.024
|
77.80 mm Hg
Standard Deviation 9.539
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 20/12h postdose
|
70.38 mm Hg
Standard Deviation 9.396
|
69.99 mm Hg
Standard Deviation 4.541
|
76.14 mm Hg
Standard Deviation 9.077
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 23/predose
|
69.46 mm Hg
Standard Deviation 10.420
|
71.55 mm Hg
Standard Deviation 6.831
|
78.88 mm Hg
Standard Deviation 3.275
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 23/2h postdose
|
66.19 mm Hg
Standard Deviation 8.480
|
68.50 mm Hg
Standard Deviation 6.328
|
77.54 mm Hg
Standard Deviation 8.795
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 23/4h postdose
|
70.49 mm Hg
Standard Deviation 9.973
|
71.54 mm Hg
Standard Deviation 7.256
|
81.34 mm Hg
Standard Deviation 6.330
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 23/8h postdose
|
72.13 mm Hg
Standard Deviation 8.899
|
74.52 mm Hg
Standard Deviation 7.792
|
82.26 mm Hg
Standard Deviation 7.506
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 23/12h postdose
|
70.92 mm Hg
Standard Deviation 8.500
|
73.93 mm Hg
Standard Deviation 6.405
|
81.14 mm Hg
Standard Deviation 6.935
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/predose (metop. 25 mg)
|
77.47 mm Hg
Standard Deviation 7.257
|
74.25 mm Hg
Standard Deviation 3.817
|
79.90 mm Hg
Standard Deviation 4.257
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/2h postdose (metop. 25 mg)
|
76.53 mm Hg
Standard Deviation 7.594
|
67.78 mm Hg
Standard Deviation 4.541
|
76.67 mm Hg
Standard Deviation 5.677
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/4h postdose (metop. 25 mg)
|
81.00 mm Hg
Standard Deviation 7.000
|
72.68 mm Hg
Standard Deviation 5.068
|
75.20 mm Hg
Standard Deviation 5.327
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/8h postdose (metop. 25 mg)
|
78.20 mm Hg
Standard Deviation 8.940
|
73.00 mm Hg
Standard Deviation 6.947
|
78.33 mm Hg
Standard Deviation 6.207
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/12h postdose (metop. 25 mg)
|
77.10 mm Hg
Standard Deviation 7.970
|
70.58 mm Hg
Standard Deviation 3.837
|
74.00 mm Hg
Standard Deviation 5.205
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/predose (metop. 25 mg)
|
69.34 mm Hg
Standard Deviation 6.846
|
71.60 mm Hg
Standard Deviation 8.405
|
83.50 mm Hg
Standard Deviation 17.678
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/2h postdose (metop. 25 mg)
|
66.74 mm Hg
Standard Deviation 6.906
|
68.28 mm Hg
Standard Deviation 7.602
|
77.85 mm Hg
Standard Deviation 14.354
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/4h postdose (metop. 25 mg)
|
66.80 mm Hg
Standard Deviation 9.121
|
69.16 mm Hg
Standard Deviation 8.603
|
78.20 mm Hg
Standard Deviation 12.021
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/8h postdose (metop. 25 mg)
|
68.52 mm Hg
Standard Deviation 7.826
|
69.54 mm Hg
Standard Deviation 10.062
|
78.00 mm Hg
Standard Deviation 15.981
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/12h postdose (metop. 25 mg)
|
67.58 mm Hg
Standard Deviation 7.949
|
69.26 mm Hg
Standard Deviation 7.755
|
78.15 mm Hg
Standard Deviation 13.930
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/predose (metop. 25 mg)
|
65.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
73.40 mm Hg
Standard Deviation 2.859
|
82.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/2h postdose (metop. 25 mg)
|
65.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
70.35 mm Hg
Standard Deviation 4.159
|
77.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/4h postdose (metop. 25 mg)
|
64.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
70.93 mm Hg
Standard Deviation 5.734
|
81.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/8h postdose (metop. 25 mg)
|
65.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
73.60 mm Hg
Standard Deviation 6.902
|
75.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/12h postdose (metop. 25 mg)
|
62.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
71.15 mm Hg
Standard Deviation 7.964
|
81.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/predose (metop. 50 mg)
|
73.90 mm Hg
Standard Deviation 7.016
|
78.33 mm Hg
Standard Deviation 10.795
|
77.50 mm Hg
Standard Deviation 9.617
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/2h postdose (metop. 50 mg)
|
67.00 mm Hg
Standard Deviation 1.179
|
71.87 mm Hg
Standard Deviation 7.467
|
73.50 mm Hg
Standard Deviation 12.445
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/4h postdose (metop. 50 mg)
|
72.23 mm Hg
Standard Deviation 4.761
|
73.00 mm Hg
Standard Deviation 6.032
|
74.80 mm Hg
Standard Deviation 10.607
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/8h postdose (metop. 50 mg)
|
67.90 mm Hg
Standard Deviation 6.537
|
72.57 mm Hg
Standard Deviation 10.657
|
71.50 mm Hg
Standard Deviation 4.525
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/2h postdose (metop. 50 mg)
|
74.23 mm Hg
Standard Deviation 4.225
|
65.95 mm Hg
Standard Deviation 3.651
|
80.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/4h postdose (metop. 50 mg)
|
75.97 mm Hg
Standard Deviation 5.033
|
69.05 mm Hg
Standard Deviation 7.023
|
82.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/8h postdose (metop. 50 mg)
|
79.77 mm Hg
Standard Deviation 9.474
|
73.33 mm Hg
Standard Deviation 4.235
|
80.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/12h postdose (metop. 50 mg)
|
74.23 mm Hg
Standard Deviation 6.933
|
66.82 mm Hg
Standard Deviation 4.704
|
80.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/predose (metop. 50 mg)
|
65.00 mm Hg
Standard Deviation 11.287
|
68.58 mm Hg
Standard Deviation 5.169
|
83.90 mm Hg
Standard Deviation 10.523
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/2h postdose (metop. 50 mg)
|
61.67 mm Hg
Standard Deviation 12.314
|
65.08 mm Hg
Standard Deviation 3.428
|
80.10 mm Hg
Standard Deviation 9.226
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/4h postdose (metop. 50 mg)
|
63.67 mm Hg
Standard Deviation 10.365
|
66.68 mm Hg
Standard Deviation 4.261
|
82.10 mm Hg
Standard Deviation 10.860
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/8h postdose (metop. 50 mg)
|
66.43 mm Hg
Standard Deviation 1.401
|
65.83 mm Hg
Standard Deviation 6.081
|
79.00 mm Hg
Standard Deviation 9.154
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/12h postdose (metop. 50 mg)
|
61.67 mm Hg
Standard Deviation 6.747
|
66.08 mm Hg
Standard Deviation 3.175
|
75.13 mm Hg
Standard Deviation 9.152
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/predose (metop. 100 mg)
|
67.43 mm Hg
Standard Deviation 9.125
|
69.95 mm Hg
Standard Deviation 4.216
|
85.00 mm Hg
Standard Deviation 12.304
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/2h postdose (metop. 100 mg)
|
62.80 mm Hg
Standard Deviation 10.641
|
63.73 mm Hg
Standard Deviation 3.037
|
78.00 mm Hg
Standard Deviation 11.314
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/4h postdose (metop. 100 mg)
|
59.13 mm Hg
Standard Deviation 10.304
|
67.78 mm Hg
Standard Deviation 5.407
|
79.00 mm Hg
Standard Deviation 6.647
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/8h postdose (metop. 100 mg)
|
62.57 mm Hg
Standard Deviation 5.954
|
67.10 mm Hg
Standard Deviation 5.255
|
82.85 mm Hg
Standard Deviation 4.455
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 15/12h postdose (metop. 100 mg)
|
58.47 mm Hg
Standard Deviation 11.898
|
64.67 mm Hg
Standard Deviation 5.343
|
77.00 mm Hg
Standard Deviation 3.818
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/predose (metop. 100 mg)
|
67.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
75.30 mm Hg
Standard Deviation 1.414
|
78.57 mm Hg
Standard Deviation 1.858
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/2h postdose (metop. 100 mg)
|
62.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
74.65 mm Hg
Standard Deviation 1.909
|
75.10 mm Hg
Standard Deviation 5.303
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/8h postdose (metop. 100 mg)
|
65.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
69.65 mm Hg
Standard Deviation 0.495
|
77.90 mm Hg
Standard Deviation 3.305
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 18/12h postdose (metop. 100 mg)
|
63.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
72.00 mm Hg
Standard Deviation 2.404
|
73.10 mm Hg
Standard Deviation 3.568
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/predose (metop. 100 mg)
|
75.08 mm Hg
Standard Deviation 8.627
|
73.62 mm Hg
Standard Deviation 6.640
|
71.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/2h postdose (metop. 100 mg)
|
72.60 mm Hg
Standard Deviation 6.741
|
69.14 mm Hg
Standard Deviation 4.944
|
68.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/4h postdose (metop. 100 mg)
|
75.52 mm Hg
Standard Deviation 6.615
|
72.60 mm Hg
Standard Deviation 5.019
|
72.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/8h postdose (metop. 100 mg)
|
75.86 mm Hg
Standard Deviation 6.464
|
72.80 mm Hg
Standard Deviation 4.727
|
74.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
DBP Day 21/12h postdose (metop. 100 mg)
|
72.06 mm Hg
Standard Deviation 5.056
|
71.86 mm Hg
Standard Deviation 3.734
|
71.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day -1/predose
|
116.30 mm Hg
Standard Deviation 8.897
|
113.51 mm Hg
Standard Deviation 6.626
|
119.97 mm Hg
Standard Deviation 7.666
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day -1/2h postdose
|
113.40 mm Hg
Standard Deviation 4.560
|
108.13 mm Hg
Standard Deviation 9.565
|
116.34 mm Hg
Standard Deviation 7.740
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day -1/4h postdose
|
115.03 mm Hg
Standard Deviation 12.772
|
112.65 mm Hg
Standard Deviation 10.492
|
118.01 mm Hg
Standard Deviation 9.510
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day -1/8h postdose
|
117.87 mm Hg
Standard Deviation 10.346
|
114.22 mm Hg
Standard Deviation 8.844
|
123.13 mm Hg
Standard Deviation 10.019
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day -1/12h postdose
|
118.97 mm Hg
Standard Deviation 11.269
|
112.79 mm Hg
Standard Deviation 11.262
|
119.76 mm Hg
Standard Deviation 9.957
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 13/predose
|
116.26 mm Hg
Standard Deviation 12.894
|
116.44 mm Hg
Standard Deviation 10.639
|
123.29 mm Hg
Standard Deviation 13.645
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 14/predose
|
116.79 mm Hg
Standard Deviation 11.931
|
115.53 mm Hg
Standard Deviation 11.630
|
123.33 mm Hg
Standard Deviation 13.602
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 14/2h postdose
|
117.11 mm Hg
Standard Deviation 10.406
|
111.74 mm Hg
Standard Deviation 10.479
|
124.29 mm Hg
Standard Deviation 14.259
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 14/4h postdose
|
118.73 mm Hg
Standard Deviation 9.790
|
116.83 mm Hg
Standard Deviation 9.799
|
125.94 mm Hg
Standard Deviation 12.902
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 14/8h postdose
|
121.03 mm Hg
Standard Deviation 11.850
|
118.69 mm Hg
Standard Deviation 12.810
|
125.01 mm Hg
Standard Deviation 13.571
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 14/12h postdose
|
121.37 mm Hg
Standard Deviation 12.372
|
117.85 mm Hg
Standard Deviation 12.695
|
124.34 mm Hg
Standard Deviation 14.504
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 17/predose
|
113.40 mm Hg
Standard Deviation 12.694
|
115.64 mm Hg
Standard Deviation 9.746
|
124.71 mm Hg
Standard Deviation 10.037
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 17/2h postdose
|
115.81 mm Hg
Standard Deviation 12.775
|
112.82 mm Hg
Standard Deviation 10.935
|
122.77 mm Hg
Standard Deviation 10.881
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 17/4h postdose
|
118.51 mm Hg
Standard Deviation 11.659
|
117.53 mm Hg
Standard Deviation 10.373
|
125.48 mm Hg
Standard Deviation 11.657
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 17/8h postdose
|
118.60 mm Hg
Standard Deviation 14.297
|
119.01 mm Hg
Standard Deviation 11.850
|
129.22 mm Hg
Standard Deviation 13.063
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 17/12h postdose
|
121.37 mm Hg
Standard Deviation 14.208
|
120.24 mm Hg
Standard Deviation 12.660
|
131.12 mm Hg
Standard Deviation 15.701
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 20/predose
|
116.07 mm Hg
Standard Deviation 12.769
|
113.80 mm Hg
Standard Deviation 11.463
|
122.52 mm Hg
Standard Deviation 16.577
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 20/2h postdose
|
114.89 mm Hg
Standard Deviation 13.293
|
113.92 mm Hg
Standard Deviation 11.205
|
126.00 mm Hg
Standard Deviation 11.011
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 20/4h postdose
|
118.20 mm Hg
Standard Deviation 11.076
|
114.44 mm Hg
Standard Deviation 10.849
|
128.54 mm Hg
Standard Deviation 13.331
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 20/8h postdose
|
120.89 mm Hg
Standard Deviation 11.552
|
117.78 mm Hg
Standard Deviation 12.058
|
127.28 mm Hg
Standard Deviation 16.690
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 20/12h postdose
|
119.97 mm Hg
Standard Deviation 13.690
|
116.58 mm Hg
Standard Deviation 10.778
|
128.62 mm Hg
Standard Deviation 11.530
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 23/predose
|
114.92 mm Hg
Standard Deviation 14.228
|
116.43 mm Hg
Standard Deviation 13.179
|
126.46 mm Hg
Standard Deviation 7.896
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 23/2h postdose
|
111.79 mm Hg
Standard Deviation 12.343
|
113.05 mm Hg
Standard Deviation 12.730
|
126.46 mm Hg
Standard Deviation 12.526
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 23/4h postdose
|
118.07 mm Hg
Standard Deviation 11.363
|
117.38 mm Hg
Standard Deviation 13.244
|
130.40 mm Hg
Standard Deviation 9.270
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 23/8h postdose
|
117.46 mm Hg
Standard Deviation 12.443
|
121.24 mm Hg
Standard Deviation 14.711
|
130.00 mm Hg
Standard Deviation 11.933
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 23/12h postdose
|
121.09 mm Hg
Standard Deviation 12.568
|
124.08 mm Hg
Standard Deviation 14.322
|
131.80 mm Hg
Standard Deviation 10.082
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/predose (metop. 25 mg)
|
121.67 mm Hg
Standard Deviation 7.343
|
118.80 mm Hg
Standard Deviation 5.916
|
120.90 mm Hg
Standard Deviation 2.476
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/2h postdose (metop. 25 mg)
|
122.80 mm Hg
Standard Deviation 11.177
|
111.50 mm Hg
Standard Deviation 6.104
|
121.67 mm Hg
Standard Deviation 4.245
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/4h postdose (metop. 25 mg)
|
124.67 mm Hg
Standard Deviation 13.683
|
117.43 mm Hg
Standard Deviation 6.098
|
117.30 mm Hg
Standard Deviation 1.000
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/8h postdose (metop. 25 mg)
|
124.80 mm Hg
Standard Deviation 12.909
|
124.35 mm Hg
Standard Deviation 13.169
|
124.23 mm Hg
Standard Deviation 5.437
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/12h postdose (metop. 25 mg)
|
126.33 mm Hg
Standard Deviation 10.398
|
119.33 mm Hg
Standard Deviation 9.947
|
121.10 mm Hg
Standard Deviation 5.986
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/predose (metop. 25 mg)
|
113.14 mm Hg
Standard Deviation 9.615
|
114.26 mm Hg
Standard Deviation 13.264
|
141.35 mm Hg
Standard Deviation 38.679
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/2h postdose (metop. 25 mg)
|
115.14 mm Hg
Standard Deviation 10.768
|
109.66 mm Hg
Standard Deviation 12.729
|
127.00 mm Hg
Standard Deviation 25.032
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/4h postdose (metop. 25 mg)
|
114.46 mm Hg
Standard Deviation 12.510
|
112.60 mm Hg
Standard Deviation 15.101
|
130.20 mm Hg
Standard Deviation 20.506
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/8h postdose (metop. 25 mg)
|
118.72 mm Hg
Standard Deviation 11.574
|
112.88 mm Hg
Standard Deviation 14.848
|
133.00 mm Hg
Standard Deviation 29.274
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/12h postdose (metop. 25 mg)
|
118.02 mm Hg
Standard Deviation 15.047
|
113.74 mm Hg
Standard Deviation 15.735
|
134.35 mm Hg
Standard Deviation 24.537
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/predose (metop. 25 mg)
|
108.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
123.15 mm Hg
Standard Deviation 16.418
|
139.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/2h postdose (metop. 25 mg)
|
116.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
115.83 mm Hg
Standard Deviation 11.601
|
133.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/4h postdose (metop. 25 mg)
|
109.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
115.50 mm Hg
Standard Deviation 14.721
|
137.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/8h postdose (metop. 25 mg)
|
111.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
118.43 mm Hg
Standard Deviation 17.039
|
121.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/12h postdose (metop. 25 mg)
|
112.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
122.00 mm Hg
Standard Deviation 16.880
|
133.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/predose (metop. 50 mg)
|
120.03 mm Hg
Standard Deviation 14.048
|
123.47 mm Hg
Standard Deviation 15.165
|
126.50 mm Hg
Standard Deviation 16.263
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/2h postdose (metop. 50 mg)
|
113.13 mm Hg
Standard Deviation 8.501
|
117.47 mm Hg
Standard Deviation 9.506
|
119.15 mm Hg
Standard Deviation 18.173
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/4h postdose (metop. 50 mg)
|
119.47 mm Hg
Standard Deviation 18.742
|
121.67 mm Hg
Standard Deviation 8.223
|
117.50 mm Hg
Standard Deviation 19.092
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/8h postdose (metop. 50 mg)
|
114.10 mm Hg
Standard Deviation 20.301
|
121.00 mm Hg
Standard Deviation 16.790
|
114.70 mm Hg
Standard Deviation 5.657
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/12h postdose (metop. 50 mg)
|
120.33 mm Hg
Standard Deviation 15.216
|
122.23 mm Hg
Standard Deviation 12.168
|
116.85 mm Hg
Standard Deviation 9.687
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/predose (metop. 50 mg)
|
124.10 mm Hg
Standard Deviation 15.650
|
115.55 mm Hg
Standard Deviation 7.441
|
122.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/4h postdose (metop. 50 mg)
|
117.47 mm Hg
Standard Deviation 6.486
|
113.12 mm Hg
Standard Deviation 14.809
|
125.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/8h postdose (metop. 50 mg)
|
124.10 mm Hg
Standard Deviation 13.028
|
123.28 mm Hg
Standard Deviation 13.124
|
117.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/12h postdose (metop. 50 mg)
|
120.90 mm Hg
Standard Deviation 12.819
|
110.22 mm Hg
Standard Deviation 10.286
|
117.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/predose (metop. 50 mg)
|
108.47 mm Hg
Standard Deviation 4.895
|
111.10 mm Hg
Standard Deviation 8.924
|
129.90 mm Hg
Standard Deviation 14.626
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/2h postdose (metop. 50 mg)
|
108.53 mm Hg
Standard Deviation 5.654
|
107.15 mm Hg
Standard Deviation 4.012
|
124.67 mm Hg
Standard Deviation 8.793
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/4h postdose (metop. 50 mg)
|
114.10 mm Hg
Standard Deviation 4.004
|
108.18 mm Hg
Standard Deviation 6.185
|
127.13 mm Hg
Standard Deviation 12.044
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/8h postdose (metop. 50 mg)
|
111.90 mm Hg
Standard Deviation 1.929
|
108.28 mm Hg
Standard Deviation 7.775
|
130.53 mm Hg
Standard Deviation 15.747
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/12h postdose (metop. 50 mg)
|
105.43 mm Hg
Standard Deviation 1.401
|
112.08 mm Hg
Standard Deviation 4.749
|
133.10 mm Hg
Standard Deviation 14.674
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/predose (metop. 100 mg)
|
112.63 mm Hg
Standard Deviation 6.429
|
114.93 mm Hg
Standard Deviation 12.018
|
136.00 mm Hg
Standard Deviation 22.203
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/2h postdose (metop. 100 mg)
|
106.47 mm Hg
Standard Deviation 7.679
|
107.40 mm Hg
Standard Deviation 10.153
|
127.20 mm Hg
Standard Deviation 21.920
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/4h postdose (metop. 100 mg)
|
105.00 mm Hg
Standard Deviation 6.000
|
111.70 mm Hg
Standard Deviation 10.995
|
124.00 mm Hg
Standard Deviation 15.556
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/8h postdose (metop. 100 mg)
|
107.37 mm Hg
Standard Deviation 4.619
|
113.60 mm Hg
Standard Deviation 13.686
|
127.65 mm Hg
Standard Deviation 12.233
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 15/12h postdose (metop. 100 mg)
|
105.97 mm Hg
Standard Deviation 3.215
|
107.37 mm Hg
Standard Deviation 12.757
|
126.50 mm Hg
Standard Deviation 13.011
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/predose (metop. 100 mg)
|
115.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
125.35 mm Hg
Standard Deviation 6.152
|
120.43 mm Hg
Standard Deviation 5.353
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/2h postdose (metop. 100 mg)
|
106.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
121.50 mm Hg
Standard Deviation 10.607
|
121.23 mm Hg
Standard Deviation 0.681
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/4h postdose (metop. 100 mg)
|
110.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
122.85 mm Hg
Standard Deviation 7.283
|
121.00 mm Hg
Standard Deviation 1.480
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/8h postdose (metop. 100 mg)
|
112.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
116.20 mm Hg
Standard Deviation 2.121
|
124.43 mm Hg
Standard Deviation 5.518
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 18/12h postdose (metop. 100 mg)
|
109.70 mm Hg
Standard Deviation 99999
|
118.15 mm Hg
Standard Deviation 6.859
|
118.90 mm Hg
Standard Deviation 4.703
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/predose (metop. 100 mg)
|
123.12 mm Hg
Standard Deviation 11.031
|
117.02 mm Hg
Standard Deviation 3.710
|
115.30 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/2h postdose (metop. 100 mg)
|
118.42 mm Hg
Standard Deviation 10.545
|
109.26 mm Hg
Standard Deviation 8.021
|
110.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/4h postdose (metop. 100 mg)
|
122.94 mm Hg
Standard Deviation 8.961
|
117.68 mm Hg
Standard Deviation 7.477
|
112.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/8h postdose (metop. 100 mg)
|
124.00 mm Hg
Standard Deviation 11.655
|
118.74 mm Hg
Standard Deviation 12.817
|
117.00 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
|
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Values After at Least 10 Minutes Rest Before Each PK Sampling Time Point or the Corresponding Time Point (Day -1, Day 13 [Pre-dose Only], Day 14, 15, 17, 18, 20, 21, 23)
SBP Day 21/12h postdose (metop. 100 mg)
|
123.60 mm Hg
Standard Deviation 11.996
|
116.74 mm Hg
Standard Deviation 10.827
|
117.70 mm Hg
Standard Deviation NA
NA=not calculated/1 subject
|
SECONDARY outcome
Timeframe: Pre-dose on Day 13, Day 14 and Day 23. Pre-dose on Day 15, Day 18 and Day 21 is listed as Metoprolol 25 mg, Metoprolol 50 mg and Metoprolol 100 mg since metoprolol was administered in randomized order.Population: Pharmacokinetic population required at least 1 quantifiable concentration, thus subjects discontinued before Day 13 were excluded. The number of participants listed below is the number of subjects with an assessment at the specified time point.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=14 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=7 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23
Day 13
|
3.293 ng/mL
Geometric Coefficient of Variation 27.94
|
8.056 ng/mL
Geometric Coefficient of Variation 35.33
|
12.20 ng/mL
Geometric Coefficient of Variation 21.29
|
|
Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23
Day 14
|
3.471 ng/mL
Geometric Coefficient of Variation 28.81
|
7.827 ng/mL
Geometric Coefficient of Variation 35.67
|
12.10 ng/mL
Geometric Coefficient of Variation 18.40
|
|
Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23
Day 23;
|
4.073 ng/mL
Geometric Coefficient of Variation 30.23
|
8.569 ng/mL
Geometric Coefficient of Variation 35.40
|
13.96 ng/mL
Geometric Coefficient of Variation 28.60
|
|
Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23
Metoprolol 25 mg
|
3.377 ng/mL
Geometric Coefficient of Variation 32.74
|
7.568 ng/mL
Geometric Coefficient of Variation 30.37
|
11.96 ng/mL
Geometric Coefficient of Variation 24.09
|
|
Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23
Metoprolol 50 mg
|
3.457 ng/mL
Geometric Coefficient of Variation 27.58
|
7.940 ng/mL
Geometric Coefficient of Variation 37.85
|
11.52 ng/mL
Geometric Coefficient of Variation 23.62
|
|
Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23
Metoprolol 100 mg
|
3.322 ng/mL
Geometric Coefficient of Variation 25.83
|
7.306 ng/mL
Geometric Coefficient of Variation 29.61
|
12.21 ng/mL
Geometric Coefficient of Variation 23.99
|
SECONDARY outcome
Timeframe: Day 15, Day 18 and Day 21Population: Pharmacokinetic (PK) population: All randomized subjects with at least 1 quantifiable tesofensine or metoprolol concentration and without major protocol deviations which could have influenced the PK.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21
Metoprolol 25 mg
|
5.215 μg/L
Geometric Coefficient of Variation 93.04
|
6.402 μg/L
Geometric Coefficient of Variation 49.71
|
6.009 μg/L
Geometric Coefficient of Variation 45.95
|
|
Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21
Metoprolol 50 mg
|
12.91 μg/L
Geometric Coefficient of Variation 61.51
|
14.91 μg/L
Geometric Coefficient of Variation 54.30
|
13.25 μg/L
Geometric Coefficient of Variation 32.13
|
|
Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21
Metoprolol 100 mg
|
22.85 μg/L
Geometric Coefficient of Variation 55.83
|
25.83 μg/L
Geometric Coefficient of Variation 46.79
|
27.59 μg/L
Geometric Coefficient of Variation 51.38
|
SECONDARY outcome
Timeframe: Day 15, Day 18 and Day 21Population: Pharmacokinetic (PK) population: All randomized subjects with at least 1 quantifiable tesofensine or metoprolol concentration and without major protocol deviations which could have influenced the PK.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21
Metoprolol 100 mg
|
4.02 hours
Interval 4.0 to 23.0
|
8.00 hours
Interval 4.0 to 12.0
|
8.04 hours
Interval 8.0 to 12.0
|
|
Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21
Metoprolol 25 mg
|
12.0 hours
Interval 8.0 to 12.0
|
8.03 hours
Interval 8.0 to 12.0
|
9.98 hours
Interval 8.0 to 12.0
|
|
Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21
Metoprolol 50 mg
|
7.98 hours
Interval 4.0 to 12.0
|
8.02 hours
Interval 4.1 to 12.0
|
10.2 hours
Interval 8.0 to 12.0
|
SECONDARY outcome
Timeframe: Day 15, Day 18 and Day 21Population: Pharmacokinetic (PK) population: All randomized subjects with at least 1 quantifiable tesofensine or metoprolol concentration and without major protocol deviations which could have influenced the PK.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From 0 to 24 h (AUC 0-24) of Metoprolol on Day 15, Day 18, and Day 21
Metoprolol 25 mg
|
91.791 h*μg/L
Geometric Coefficient of Variation 87.70
|
105.41 h*μg/L
Geometric Coefficient of Variation 51.46
|
104.90 h*μg/L
Geometric Coefficient of Variation 54.76
|
|
Area Under the Concentration-time Curve From 0 to 24 h (AUC 0-24) of Metoprolol on Day 15, Day 18, and Day 21
Metoprolol 50 mg
|
203.19 h*μg/L
Geometric Coefficient of Variation 65.50
|
240.92 h*μg/L
Geometric Coefficient of Variation 58.21
|
221.59 h*μg/L
Geometric Coefficient of Variation 28.47
|
|
Area Under the Concentration-time Curve From 0 to 24 h (AUC 0-24) of Metoprolol on Day 15, Day 18, and Day 21
Metoprolol 100 mg
|
392.70 h*μg/L
Geometric Coefficient of Variation 67.88
|
458.35 h*μg/L
Geometric Coefficient of Variation 52.06
|
466.34 h*μg/L
Geometric Coefficient of Variation 45.85
|
SECONDARY outcome
Timeframe: Day before dosing (Days 14, 17, 20), dosing day (Days 15, 18, 21) and two days after dosing (Days 17, 20, 23)Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Heart Rate (HR) Stratified by Metoprolol Concentration
Metoprolol 50 mg; Two days after dosing
|
76.2 bpm
Standard Deviation 10.06
|
82.1 bpm
Standard Deviation 7.22
|
83.0 bpm
Standard Deviation 7.11
|
|
Heart Rate (HR) Stratified by Metoprolol Concentration
Metoprolol 25 mg; Day before dosing
|
73.8 bpm
Standard Deviation 9.96
|
79.4 bpm
Standard Deviation 8.13
|
82.2 bpm
Standard Deviation 7.41
|
|
Heart Rate (HR) Stratified by Metoprolol Concentration
Metoprolol 25 mg; Dosing day
|
71.1 bpm
Standard Deviation 9.45
|
76.5 bpm
Standard Deviation 7.68
|
80.0 bpm
Standard Deviation 7.71
|
|
Heart Rate (HR) Stratified by Metoprolol Concentration
Metoprolol 25 mg; Two days after dosing
|
76.8 bpm
Standard Deviation 10.94
|
82.1 bpm
Standard Deviation 8.88
|
85.7 bpm
Standard Deviation 7.47
|
|
Heart Rate (HR) Stratified by Metoprolol Concentration
Metoprolol 50 mg; Day before dosing
|
74.3 bpm
Standard Deviation 9.62
|
78.7 bpm
Standard Deviation 5.47
|
85.5 bpm
Standard Deviation 7.92
|
|
Heart Rate (HR) Stratified by Metoprolol Concentration
Metoprolol 50 mg; Dosing day
|
69.6 bpm
Standard Deviation 9.40
|
73.9 bpm
Standard Deviation 5.75
|
80.8 bpm
Standard Deviation 7.83
|
|
Heart Rate (HR) Stratified by Metoprolol Concentration
Metoprolol 100 mg; Day before dosing
|
75.2 bpm
Standard Deviation 9.30
|
77.6 bpm
Standard Deviation 5.47
|
81.2 bpm
Standard Deviation 5.26
|
|
Heart Rate (HR) Stratified by Metoprolol Concentration
Metoprolol 100 mg; Dosing day
|
69.2 bpm
Standard Deviation 9.46
|
70.7 bpm
Standard Deviation 6.05
|
73.6 bpm
Standard Deviation 3.91
|
|
Heart Rate (HR) Stratified by Metoprolol Concentration
Metoprolol 100 mg; Two days after dosing
|
76.6 bpm
Standard Deviation 10.13
|
78.8 bpm
Standard Deviation 4.26
|
84.4 bpm
Standard Deviation 8.91
|
SECONDARY outcome
Timeframe: From baseline to Day 23Population: Pharmacodynamic population required heart rate (HR) at baseline and at least 2 visits out of Day 15, Day 18, Day 21, thus subjects discontinued before Day 18 were excluded. The number of participants listed below is the number of subjects with an assessment at given time point.
The difference in increase in M24HR caused by tesofensine alone (calculated as the difference between the M24HR at pre-tesofensine baseline and the mean of M24HR on Days 14, 17, 20 and 23) and the reduction in M24HR following each of the 3 metoprolol doses (M24HR on Day 15, 18 or 21).
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=13 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=6 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose
Metoprolol 25 mg
|
-1.17 bpm
Interval -4.84 to 2.49
|
3.55 bpm
Interval 0.34 to 6.77
|
6.97 bpm
Interval 4.77 to 9.16
|
|
Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose
Metoprolol 50 mg
|
-2.99 bpm
Interval -6.63 to 0.65
|
0.88 bpm
Interval -2.34 to 4.11
|
7.98 bpm
Interval 5.91 to 10.15
|
|
Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose
Metoprolol 100 mg
|
-3.59 bpm
Interval -7.25 to 0.08
|
-2.13 bpm
Interval -5.37 to 1.1
|
0.45 bpm
Interval -2.04 to 2.94
|
SECONDARY outcome
Timeframe: Day -1, Day 13 [pre-dose only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23Population: All subjects included in the study and dosed with IMP were included in the safety population. The number of participants listed below is the number of subjects with an assessment at the specified time point.
Mean of triplicated QT Interval
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=16 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=12 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Mean of Triplicated QT Interval
Day 15/12h postdose (metop. 50 mg)
|
392.63 msec
Standard Deviation 29.143
|
383.53 msec
Standard Deviation 0.404
|
378.00 msec
Standard Deviation 2.828
|
|
Mean of Triplicated QT Interval
Day 18/predose (metop. 50 mg)
|
396.20 msec
Standard Deviation 30.513
|
385.75 msec
Standard Deviation 18.862
|
381.30 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 18/2h postdose (metop. 50 mg)
|
387.13 msec
Standard Deviation 41.727
|
377.53 msec
Standard Deviation 7.314
|
346.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 18/4h postdose (metop. 50 mg)
|
410.03 msec
Standard Deviation 45.622
|
390.88 msec
Standard Deviation 16.413
|
358.00 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 18/8h postdose (metop. 50 mg)
|
406.20 msec
Standard Deviation 40.115
|
400.00 msec
Standard Deviation 27.450
|
396.00 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 18/12h postdose (metop. 50 mg)
|
399.77 msec
Standard Deviation 45.018
|
388.57 msec
Standard Deviation 19.421
|
374.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 21/predose (metop. 50 mg)
|
406.43 msec
Standard Deviation 13.952
|
388.98 msec
Standard Deviation 15.647
|
378.43 msec
Standard Deviation 37.456
|
|
Mean of Triplicated QT Interval
Day 21/2h postdose (metop. 50 mg)
|
391.57 msec
Standard Deviation 7.769
|
377.18 msec
Standard Deviation 22.436
|
371.57 msec
Standard Deviation 20.096
|
|
Mean of Triplicated QT Interval
Day 21/4h postdose (metop. 50 mg)
|
402.87 msec
Standard Deviation 15.658
|
394.68 msec
Standard Deviation 21.586
|
388.90 msec
Standard Deviation 26.117
|
|
Mean of Triplicated QT Interval
Day 21/8h postdose (metop. 50 mg)
|
419.30 msec
Standard Deviation 19.287
|
404.48 msec
Standard Deviation 14.866
|
388.23 msec
Standard Deviation 22.649
|
|
Mean of Triplicated QT Interval
Day 21/12h postdose (metop. 50 mg)
|
407.80 msec
Standard Deviation 1.559
|
391.03 msec
Standard Deviation 18.953
|
379.10 msec
Standard Deviation 22.060
|
|
Mean of Triplicated QT Interval
Day 15/predose (metop. 100 mg)
|
381.10 msec
Standard Deviation 12.842
|
391.55 msec
Standard Deviation 16.914
|
397.65 msec
Standard Deviation 44.760
|
|
Mean of Triplicated QT Interval
Day 15/2h postdose (metop. 100 mg)
|
387.10 msec
Standard Deviation 13.146
|
382.22 msec
Standard Deviation 10.369
|
388.65 msec
Standard Deviation 15.061
|
|
Mean of Triplicated QT Interval
Day 15/4h postdose (metop. 100 mg)
|
419.77 msec
Standard Deviation 27,802
|
406.12 msec
Standard Deviation 17.056
|
406.65 msec
Standard Deviation 24.537
|
|
Mean of Triplicated QT Interval
Day 15/8h postdose (metop. 100 mg)
|
419.33 msec
Standard Deviation 10.081
|
400.45 msec
Standard Deviation 27.301
|
414.65 msec
Standard Deviation 10.394
|
|
Mean of Triplicated QT Interval
Day 15/12h postdose (metop. 100 mg)
|
414.43 msec
Standard Deviation 5.954
|
396.68 msec
Standard Deviation 14.125
|
398.00 msec
Standard Deviation 18.809
|
|
Mean of Triplicated QT Interval
Day 18/predose (metop. 100 mg)
|
389.30 msec
Standard Deviation NA
NA=not calculated/1subj.
|
391.00 msec
Standard Deviation 15.556
|
380.90 msec
Standard Deviation 16.536
|
|
Mean of Triplicated QT Interval
Day 18/2h postdose (metop. 100 mg)
|
371.30 msec
Standard Deviation NA
NA=not calculated/1subj.
|
375.00 msec
Standard Deviation 14.566
|
374.00 msec
Standard Deviation 14.117
|
|
Mean of Triplicated QT Interval
Day 18/4h postdose (metop. 100 mg)
|
380.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
392.65 msec
Standard Deviation 20.718
|
391.53 msec
Standard Deviation 16.762
|
|
Mean of Triplicated QT Interval
Day 18/8h postdose (metop. 100 mg)
|
386.00 msec
Standard Deviation NA
NA=not calculated/1subj.
|
405.00 msec
Standard Deviation 21.213
|
392.87 msec
Standard Deviation 18.329
|
|
Mean of Triplicated QT Interval
Day 18/12h postdose (metop. 100 mg)
|
369.30 msec
Standard Deviation NA
NA=not calculated/1subj.
|
393.00 msec
Standard Deviation 7.071
|
382.87 msec
Standard Deviation 20.429
|
|
Mean of Triplicated QT Interval
Day 21/predose (metop. 100 mg)
|
406.80 msec
Standard Deviation 39.537
|
387.20 msec
Standard Deviation 14.916
|
390.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 21/2h postdose (metop. 100 mg)
|
383.60 msec
Standard Deviation 37.938
|
374.78 msec
Standard Deviation 16.698
|
410.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 21/4h postdose (metop. 100 mg)
|
400.78 msec
Standard Deviation 38.353
|
396.24 msec
Standard Deviation 17.208
|
428.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 21/8h postdose (metop. 100 mg)
|
410.94 msec
Standard Deviation 38.128
|
399.74 msec
Standard Deviation 24.355
|
428.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 21/12h postdose (metop. 100 mg)
|
393.48 msec
Standard Deviation 38.721
|
387.60 msec
Standard Deviation 16.030
|
402.00 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 23/8h postdose
|
388.30 msec
Standard Deviation 28.021
|
375.13 msec
Standard Deviation 21.611
|
381.86 msec
Standard Deviation 19.204
|
|
Mean of Triplicated QT Interval
Day 23/12h postdose
|
376.07 msec
Standard Deviation 22.251
|
365.06 msec
Standard Deviation 19.474
|
371.62 msec
Standard Deviation 18.763
|
|
Mean of Triplicated QT Interval
Day 15/predose (metop. 25 mg)
|
403.10 msec
Standard Deviation 24.701
|
395.35 msec
Standard Deviation 5.735
|
384.00 msec
Standard Deviation 7.436
|
|
Mean of Triplicated QT Interval
Day 15/2h postdose (metop. 25 mg)
|
376.23 msec
Standard Deviation 31.405
|
384.83 msec
Standard Deviation 7.265
|
374.67 msec
Standard Deviation 9.820
|
|
Mean of Triplicated QT Interval
Day 15/4h postdose (metop. 25 mg)
|
392.20 msec
Standard Deviation 32.336
|
396.15 msec
Standard Deviation 9.293
|
384.23 msec
Standard Deviation 7.125
|
|
Mean of Triplicated QT Interval
Day 15/8h postdose (metop. 25 mg)
|
399.33 msec
Standard Deviation 36.382
|
397.18 msec
Standard Deviation 15.108
|
388.67 msec
Standard Deviation 13.785
|
|
Mean of Triplicated QT Interval
Day 15/12h postdose (metop. 25 mg)
|
396.43 msec
Standard Deviation 51.651
|
392.33 msec
Standard Deviation 12.747
|
378.20 msec
Standard Deviation 14.901
|
|
Mean of Triplicated QT Interval
Day 18/predose (metop. 25 mg)
|
405.48 msec
Standard Deviation 26.341
|
396.12 msec
Standard Deviation 15.396
|
363.35 msec
Standard Deviation 29.204
|
|
Mean of Triplicated QT Interval
Day 18/2h postdose (metop. 25 mg)
|
394.94 msec
Standard Deviation 16.701
|
384.52 msec
Standard Deviation 10.925
|
381.35 msec
Standard Deviation 27.365
|
|
Mean of Triplicated QT Interval
Day 18/4h postdose (metop. 25 mg)
|
412.14 msec
Standard Deviation 22.650
|
399.46 msec
Standard Deviation 17.580
|
386.00 msec
Standard Deviation 29.274
|
|
Mean of Triplicated QT Interval
Day 18/8h postdose (metop. 25 mg)
|
411.86 msec
Standard Deviation 16.278
|
389.48 msec
Standard Deviation 15.161
|
378.30 msec
Standard Deviation 35.355
|
|
Mean of Triplicated QT Interval
Day 18/12h postdose (metop. 25 mg)
|
401.06 msec
Standard Deviation 17.177
|
378.94 msec
Standard Deviation 16.214
|
364.65 msec
Standard Deviation 12.233
|
|
Mean of Triplicated QT Interval
Day 21/predose (metop. 25 mg)
|
368.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
370.15 msec
Standard Deviation 13.164
|
384.00 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 21/2h postdose (metop. 25 mg)
|
376.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
358.68 msec
Standard Deviation 12.613
|
375.30 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 21/4h postdose (metop. 25 mg)
|
358.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
372.48 msec
Standard Deviation 8.330
|
376.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 21/8h postdose (metop. 25 mg)
|
386.00 msec
Standard Deviation NA
NA=not calculated/1subj.
|
381.35 msec
Standard Deviation 18.034
|
395.30 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 21/12h postdose (metop. 25 mg)
|
372.70 msec
Standard Deviation NA
NA=not calculated/1subj.
|
374.18 msec
Standard Deviation 12.217
|
366.00 msec
Standard Deviation NA
NA=not calculated/1subj.
|
|
Mean of Triplicated QT Interval
Day 15/predose (metop. 50 mg)
|
408.20 msec
Standard Deviation 29.360
|
388.67 msec
Standard Deviation 17.402
|
372.30 msec
Standard Deviation 18.385
|
|
Mean of Triplicated QT Interval
Day 15/2h postdose (metop. 50 mg)
|
386.67 msec
Standard Deviation 34.141
|
373.77 msec
Standard Deviation 15.187
|
380.35 msec
Standard Deviation 36.275
|
|
Mean of Triplicated QT Interval
Day 15/4h postdose (metop. 50 mg)
|
396.87 msec
Standard Deviation 39.405
|
393.80 msec
Standard Deviation 12.387
|
375.00 msec
Standard Deviation 38.184
|
|
Mean of Triplicated QT Interval
Day 15/8h postdose (metop. 50 mg)
|
405.57 msec
Standard Deviation 25.408
|
390.47 msec
Standard Deviation 3.281
|
393.00 msec
Standard Deviation 21.213
|
|
Mean of Triplicated QT Interval
Day -1/predose
|
400.00 msec
Standard Deviation 23.654
|
398.08 msec
Standard Deviation 22.518
|
404.28 msec
Standard Deviation 31.567
|
|
Mean of Triplicated QT Interval
Day -1/2h postdose
|
381.83 msec
Standard Deviation 20.867
|
375.76 msec
Standard Deviation 15.028
|
386.66 msec
Standard Deviation 30.168
|
|
Mean of Triplicated QT Interval
Day -1/4h postdose
|
388.29 msec
Standard Deviation 27.746
|
385.91 msec
Standard Deviation 14.718
|
396.34 msec
Standard Deviation 28.389
|
|
Mean of Triplicated QT Interval
Day -1/8h postdose
|
395.78 msec
Standard Deviation 22.869
|
391.67 msec
Standard Deviation 16.588
|
395.12 msec
Standard Deviation 19.830
|
|
Mean of Triplicated QT Interval
Day -1/12h postdose
|
378.00 msec
Standard Deviation 26.099
|
385.30 msec
Standard Deviation 16.044
|
387.56 msec
Standard Deviation 28.855
|
|
Mean of Triplicated QT Interval
Day 13/predose
|
404.14 msec
Standard Deviation 24.739
|
384.81 msec
Standard Deviation 13.394
|
390.59 msec
Standard Deviation 19.371
|
|
Mean of Triplicated QT Interval
Day 14/predose
|
402.81 msec
Standard Deviation 28.425
|
396.81 msec
Standard Deviation 13.317
|
398.19 msec
Standard Deviation 16.649
|
|
Mean of Triplicated QT Interval
Day 14/2h postdose
|
392.37 msec
Standard Deviation 30.650
|
386.39 msec
Standard Deviation 18.472
|
383.24 msec
Standard Deviation 18.341
|
|
Mean of Triplicated QT Interval
Day 14/4h postdose
|
398.01 msec
Standard Deviation 30.117
|
385.48 msec
Standard Deviation 14.826
|
389.43 msec
Standard Deviation 18.661
|
|
Mean of Triplicated QT Interval
Day 14/8h postdose
|
396.82 msec
Standard Deviation 30.306
|
386.01 msec
Standard Deviation 16.595
|
389.64 msec
Standard Deviation 16.190
|
|
Mean of Triplicated QT Interval
Day 14/12h postdose
|
386.01 msec
Standard Deviation 28.991
|
379.14 msec
Standard Deviation 17.101
|
375.43 msec
Standard Deviation 19.292
|
|
Mean of Triplicated QT Interval
Day 17/predose
|
405.10 msec
Standard Deviation 29.008
|
392.72 msec
Standard Deviation 19.161
|
393.53 msec
Standard Deviation 16.439
|
|
Mean of Triplicated QT Interval
Day 17/2h postdose
|
391.99 msec
Standard Deviation 31.469
|
377.69 msec
Standard Deviation 14.665
|
371.45 msec
Standard Deviation 14.113
|
|
Mean of Triplicated QT Interval
Day 17/4h postdose
|
400.02 msec
Standard Deviation 29.034
|
390.76 msec
Standard Deviation 16.704
|
382.88 msec
Standard Deviation 10.457
|
|
Mean of Triplicated QT Interval
Day 17/8h postdose
|
393.98 msec
Standard Deviation 25.616
|
384.11 msec
Standard Deviation 17.812
|
382.00 msec
Standard Deviation 9.674
|
|
Mean of Triplicated QT Interval
Day 17/12h postdose
|
378.51 msec
Standard Deviation 27.115
|
374.83 msec
Standard Deviation 10.381
|
368.33 msec
Standard Deviation 11.941
|
|
Mean of Triplicated QT Interval
Day 20/predose
|
407.56 msec
Standard Deviation 28.115
|
390.52 msec
Standard Deviation 16.942
|
389.34 msec
Standard Deviation 16.182
|
|
Mean of Triplicated QT Interval
Day 20/2h postdose
|
390.23 msec
Standard Deviation 31.513
|
374.25 msec
Standard Deviation 13.470
|
376.68 msec
Standard Deviation 11.908
|
|
Mean of Triplicated QT Interval
Day 20/4h postdose
|
403.62 msec
Standard Deviation 31.402
|
384.93 msec
Standard Deviation 15.006
|
385.20 msec
Standard Deviation 22.302
|
|
Mean of Triplicated QT Interval
Day 20/8h postdose
|
398.67 msec
Standard Deviation 33.745
|
381.07 msec
Standard Deviation 13.220
|
392.26 msec
Standard Deviation 23.255
|
|
Mean of Triplicated QT Interval
Day 20/12h postdose
|
382.29 msec
Standard Deviation 35.547
|
368.41 msec
Standard Deviation 14.193
|
377.08 msec
Standard Deviation 17.626
|
|
Mean of Triplicated QT Interval
Day 23/predose
|
403.10 msec
Standard Deviation 25.565
|
382.83 msec
Standard Deviation 19.770
|
387.76 msec
Standard Deviation 20.460
|
|
Mean of Triplicated QT Interval
Day 23/2h postdose
|
385.78 msec
Standard Deviation 24.461
|
371.06 msec
Standard Deviation 14.921
|
369.74 msec
Standard Deviation 18.183
|
|
Mean of Triplicated QT Interval
Day 23/4h postdose
|
394.16 msec
Standard Deviation 31.839
|
378.17 msec
Standard Deviation 19.816
|
386.14 msec
Standard Deviation 24.694
|
SECONDARY outcome
Timeframe: 30 days prior to Screening until the Safety Follow-up phone call, up to Day 50Any medicinal product, prescribed or over-the-counter (OTC), including herbal and other non-traditional remedies, was considered a concomitant medication.
Outcome measures
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 Participants
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=16 Participants
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=12 Participants
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
ACETYLSALICYLIC ACID/concomitant
|
1 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
BEPANTHEN/concomitant
|
2 Count of participants
|
0 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
PARACETAMOL/concomitant
|
1 Count of participants
|
2 Count of participants
|
1 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
ANAESTHETICS, LOCAL/concomitant
|
0 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
IBUPROFEN/concomitant
|
0 Count of participants
|
2 Count of participants
|
1 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
METOPROLOL TARTRATE/concomitant
|
0 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
PANTOPRAZOLE/concomitant
|
0 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
UNACID [AMPICILLIN SODIUM;SULBACTAM SODIUM]/conco.
|
0 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
IBUPROFEN/prior
|
0 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
FOLIC ACID/concomitant
|
0 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
METEX [METHOTREXATE SODIUM]/concomitant
|
0 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
PREDNISOLONE/concomitant
|
0 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
METOPROLOL SUCCINATE/concomitant
|
0 Count of participants
|
1 Count of participants
|
0 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
HALOPERIDOL/concomitant
|
0 Count of participants
|
0 Count of participants
|
1 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
LORAZEPAM/concomitant
|
0 Count of participants
|
0 Count of participants
|
1 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
METOCLOPRAMIDE/concomitant
|
0 Count of participants
|
0 Count of participants
|
1 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
RISPERIDON BETA/concomitant
|
0 Count of participants
|
0 Count of participants
|
1 Count of participants
|
|
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
PARACETAMOL/prior
|
0 Count of participants
|
0 Count of participants
|
1 Count of participants
|
Adverse Events
Cohort 1 (Tesofensine 0.25mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2 (Tesofensine 0.50mg)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 3 (Tesofensine 0.75mg)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 participants at risk
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=16 participants at risk
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=12 participants at risk
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Psychiatric disorders
Hypomania
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Impulse-control disorder
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
Other adverse events
| Measure |
Cohort 1 (Tesofensine 0.25mg)
n=9 participants at risk
Tesofensine 0.25 mg once daily for 23 days (loading dose of 1.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 2 (Tesofensine 0.50mg)
n=16 participants at risk
Tesofensine 0.50 mg once daily for 23 days (loading dose of 2.0 mg for the first 3 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
Cohort 3 (Tesofensine 0.75mg)
n=12 participants at risk
Tesofensine 0.75 mg (0.25 mg + 0.50 mg) once daily for 23 days (loading dose of 2.0 mg \[4 tablets of 0.50 mg\] for the first 5 days), plus a single dose of 25 mg, 50 mg or 100 mg metoprolol extended release (ER) in random order on Day 15, Day 18 and Day 21, respectively.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Cardiac disorders
Palpitations
|
44.4%
4/9 • Number of events 7 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
43.8%
7/16 • Number of events 8 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
41.7%
5/12 • Number of events 8 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Eye disorders
Visual impairment
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
16.7%
2/12 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
31.2%
5/16 • Number of events 5 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
16.7%
2/12 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
31.2%
5/16 • Number of events 5 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Asthenia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Chest discomfort
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Energy increased
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Exercise tolerance
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Fatigue
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Feeling abnormal
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
25.0%
3/12 • Number of events 4 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Feeling cold
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Feeling hot
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Feeling of relaxation
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Mucosal dryness
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Thirst
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Investigations
Blood pressure increased
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
3/9 • Number of events 3 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
68.8%
11/16 • Number of events 11 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
75.0%
9/12 • Number of events 9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Disturbance in attention
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
18.8%
3/16 • Number of events 3 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
18.8%
3/16 • Number of events 5 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
25.0%
3/12 • Number of events 4 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Dizziness postural
|
22.2%
2/9 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
16.7%
2/12 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Facial neuralgia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Number of events 7 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
31.2%
5/16 • Number of events 5 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
50.0%
6/12 • Number of events 6 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
18.8%
3/16 • Number of events 3 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
25.0%
3/12 • Number of events 3 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
18.8%
3/16 • Number of events 4 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Agitation
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
16.7%
2/12 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Euphoric mood
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
37.5%
6/16 • Number of events 6 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
33.3%
4/12 • Number of events 4 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Fear
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Illusion
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
18.8%
3/16 • Number of events 3 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
25.0%
3/12 • Number of events 3 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Listless
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Restlessness
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
43.8%
7/16 • Number of events 7 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
41.7%
5/12 • Number of events 6 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Tension
|
22.2%
2/9 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
25.0%
4/16 • Number of events 4 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
16.7%
2/12 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Thinking abnormal
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Psychiatric disorders
Tic
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Renal and urinary disorders
Pollakisuria
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
8.3%
1/12 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Vascular disorders
Hot flush
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
16.7%
2/12 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Gastrointestinal disorders
Rash
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Catheter site pain
|
11.1%
1/9 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Chest pain
|
11.1%
1/9 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
General disorders
Medical device site reaction
|
33.3%
3/9 • Number of events 3 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/16 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
22.2%
2/9 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Surgical and medical procedures
Finger repair operation
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
0.00%
0/12 • From first dose of study drug through Day 50
Adverse events are reported per tesofensine dose group. Differentiation per metoprolol dose could not be delineated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place