Trial Outcomes & Findings for Study to Investigate the Pharmacokinetic Profile (NCT NCT03286829)
NCT ID: NCT03286829
Last Updated: 2020-05-14
Results Overview
Area under the concentration-time curve from pre-dose (time 0) to 48 hours post-dose calculated using the linear-log trapezoidal rule
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-dose
Results posted on
2020-05-14
Participant Flow
Participant milestones
| Measure |
Tesomet "High Dose" in Fasted Condition
A Tesomet FDC tablet (20 mg immediate release \[IR\] metoprolol, 1 mg tesofensine, 80 mg extended release \[ER\] metoprolol) in fasted condition ("High" dose)
|
Tesomet "Low Dose" in Fasted Condition
A Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. ("Low" dose)
|
Comparator
1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
|
Tesomet "High Dose" in Fed Condition
A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition ("High" dose)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Pharmacokinetic Profile
Baseline characteristics by cohort
| Measure |
Tesomet "High Dose" in Fasted Condition
n=15 Participants
Tesomet FDC tablet (20 mg immediate release \[IR\] metoprolol, 1 mg tesofensine, 80 mg extended release \[ER\] metoprolol) in fasted condition ("High" dose)
|
Tesomet "Low Dose" in Fasted Condition
n=15 Participants
Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. ("Low" dose)
|
Comparator
n=15 Participants
1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
|
Tesomet "High Dose" in Fed Condition
n=15 Participants
Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition ("High" dose)
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 11.55 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 8.81 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 9.91 • n=4 Participants
|
40.7 years
STANDARD_DEVIATION 9.93 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
60 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-doseArea under the concentration-time curve from pre-dose (time 0) to 48 hours post-dose calculated using the linear-log trapezoidal rule
Outcome measures
| Measure |
Tesomet "High Dose" in Fasted Condition
n=15 Participants
Tesomet FDC tablet (20 mg immediate release \[IR\] metoprolol, 1 mg tesofensine, 80 mg extended release \[ER\] metoprolol) in fasted condition ("High" dose)
|
Tesomet "Low Dose" in Fasted Condition
n=15 Participants
Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. ("Low" dose)
|
Comparator
n=15 Participants
1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
|
Tesomet "High Dose" in Fed Condition
n=15 Participants
A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition ("High" dose)
|
|---|---|---|---|---|
|
AUC0-48
|
32.06 ng*hr/mL
Geometric Coefficient of Variation 26.9
|
6.491 ng*hr/mL
Geometric Coefficient of Variation 25.1
|
45.89 ng*hr/mL
Geometric Coefficient of Variation 21.9
|
30.14 ng*hr/mL
Geometric Coefficient of Variation 18.6
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-doseMaximum tesofensine and metoprolol concentrations determined directly from the concentration-time profile
Outcome measures
| Measure |
Tesomet "High Dose" in Fasted Condition
n=15 Participants
Tesomet FDC tablet (20 mg immediate release \[IR\] metoprolol, 1 mg tesofensine, 80 mg extended release \[ER\] metoprolol) in fasted condition ("High" dose)
|
Tesomet "Low Dose" in Fasted Condition
n=15 Participants
Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. ("Low" dose)
|
Comparator
n=15 Participants
1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
|
Tesomet "High Dose" in Fed Condition
n=15 Participants
A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition ("High" dose)
|
|---|---|---|---|---|
|
Cmax
|
0.9528 ng/mL
Geometric Coefficient of Variation 25.5
|
0.1934 ng/mL
Geometric Coefficient of Variation 23.6
|
1.357 ng/mL
Geometric Coefficient of Variation 23.8
|
0.8085 ng/mL
Geometric Coefficient of Variation 17.1
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30, 36 and 48 hours post-doseTime of maximum tesofensine and metoprolol concentrations determined directly from the concentration-time profile
Outcome measures
| Measure |
Tesomet "High Dose" in Fasted Condition
n=15 Participants
Tesomet FDC tablet (20 mg immediate release \[IR\] metoprolol, 1 mg tesofensine, 80 mg extended release \[ER\] metoprolol) in fasted condition ("High" dose)
|
Tesomet "Low Dose" in Fasted Condition
n=15 Participants
Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. ("Low" dose)
|
Comparator
n=15 Participants
1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
|
Tesomet "High Dose" in Fed Condition
n=15 Participants
A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition ("High" dose)
|
|---|---|---|---|---|
|
Tmax
|
6.12 hours
Geometric Coefficient of Variation 5.98
|
6.00 hours
Geometric Coefficient of Variation 5.98
|
6.00 hours
Geometric Coefficient of Variation 3.98
|
8.00 hours
Geometric Coefficient of Variation 4.00
|
Adverse Events
Tesomet "High Dose" in Fasted Condition
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Tesomet "Low Dose" in Fasted Condition
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Comparator
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Tesomet "High Dose" in Fed Condition
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tesomet "High Dose" in Fasted Condition
n=15 participants at risk
A Tesomet FDC tablet (20 mg immediate release \[IR\] metoprolol, 1 mg tesofensine, 80 mg extended release \[ER\] metoprolol) in fasted condition ("High" dose)
|
Tesomet "Low Dose" in Fasted Condition
n=15 participants at risk
A Tesomet FDC tablet (5 mg immediate IR metoprolol, 0.2 mg tesofensine, 20 mg ER metoprolol) in fasted condition. ("Low" dose)
|
Comparator
n=15 participants at risk
1 mg tesofensine (2 tablets of 0.5 mg), 25 mg commercial IR metoprolol (1 tablet of 25 mg), 75 mg commercial ER metoprolol (1 tablet of 25 mg ER metoprolol and 1 tablet of 50 mg ER metoprolol), fasted condition
|
Tesomet "High Dose" in Fed Condition
n=15 participants at risk
A Tesomet FDC tablet (20 mg immediate IR metoprolol, 1 mg tesofensine, 80 mg ER metoprolol in fed condition ("High" dose)
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • 38days
|
6.7%
1/15 • Number of events 1 • 38days
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
|
General disorders
catheter side reaction
|
0.00%
0/15 • 38days
|
6.7%
1/15 • Number of events 1 • 38days
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
6.7%
1/15 • Number of events 1 • 38days
|
0.00%
0/15 • 38days
|
|
General disorders
Asthenia
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
6.7%
1/15 • Number of events 1 • 38days
|
0.00%
0/15 • 38days
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • 38days
|
6.7%
1/15 • Number of events 1 • 38days
|
13.3%
2/15 • Number of events 2 • 38days
|
0.00%
0/15 • 38days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
6.7%
1/15 • Number of events 1 • 38days
|
6.7%
1/15 • Number of events 1 • 38days
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
6.7%
1/15 • Number of events 1 • 38days
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • 38days
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/15 • 38days
|
6.7%
1/15 • Number of events 1 • 38days
|
0.00%
0/15 • 38days
|
0.00%
0/15 • 38days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place