Phase 1
Conditions
Brief summary
A Phase 1 Study to Examine Pharmacodynamic Interaction Between Tesofensine and Metoprolol on 24-hours Mean Heart Rate
Detailed description
In this study, the dose-response relationship between tesofensine and metoprolol will be examined and thus the optimal dose of metoprolol to mitigate the effects of tesofensine on heart rate (HR) will be determined. HR is the primary endpoint because in the previous studies it has been shown to be the most affected safety endpoint by the effects of tesofensine. After enrolment of 37 subjects, 2 Subjects (0115 and 0147) in dose cohort 2 experienced prolonged tachycardia (\> 120 beats per minute (bpm) lasting for 30 min) documented in Holter Electrocardiogram (ECG) recording (a stopping criteria of the study). Therefore, the study was temporarily halted on 22 November 2018. Subsequent to the temporary halt, Saniona reviewed all the available data in January and February 2019 and determined that the results obtained from the completed participants were sufficiently robust to answer the questions for which the trial was designed. Therefore, Saniona decided to permanently end the trial on 20 February 2019.
Interventions
DRUGMetoprolol Succinate 25 MG
A single dose of 25 mg metoprolol ER in the morning of Day 15, Day 18 or Day 21 approximately 30 minutes after start of a standard breakfast and together with the tesofensine dose.
DRUGMetoprolol Succinate 50 MG
A single dose of 50 mg metoprolol ER in the morning of Day 15, Day 18 or Day 21 approximately 30 minutes after start of a standard breakfast and together with the tesofensine dose.
DRUGMetoprolol Succinate 100 MG
A single dose of 100 mg metoprolol ER in the morning of Day 15, Day 18 or Day 21, approximately 30 minutes after start of a standard breakfast and together with the tesofensine dose.
Sponsors
Saniona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Tesofensine dosing will be performed open-label. Metoprolol dosing will be performed single-blind.
Intervention model description
Each subject will participate in a Screening Period (Day 28 to Day 3), a Baseline Period (Day -2 to Day -1) and a Treatment Period (Day 1 to Day 24) and will have two Follow-up phone calls (Day 30 and Day 50).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject voluntarily agreed to participate in this study and signed an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening procedures. 2. Male and female subjects between 18 to 60 years of age, inclusive, at Screening. 3. Overweight and obese subjects with a body mass index (BMI) between ≥ 27 and \< 40 kg/m2 at Screening but otherwise healthy. 4. Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (\< 500 ng/mL) at Screening and admission. 5. No clinically relevant deviation or finding in pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations). 6. Hemoglobin A1c (HbA1c) \< 6.5% at Screening. 7. Subject was willing to adhere to the contraception requirements details.
Exclusion criteria
1. Subject had history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic (e.g., diabetes, metabolic acidosis), urologic, pulmonary (e.g., asthma or chronic obstructive pulmonary disease), neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the Investigator. 2. Subject had any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs. 3. Subject had a clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol (CSP)-defined clinical laboratory tests at Screening or admission to the clinical unit or had any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the clinical study. One re-test was allowed, if (a) test result(s) was outside the limits. 4. History or presence of liver disease or liver injury, as indicated by abnormal liver function tests including: * Aspartate aminotransferase (AST) \> 1.2 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) \> 1.1 x upper limit of normal (ULN) 5. Subject had a pulse \< 50 or \> 90 beats per minute (bpm); systolic blood pressure (SBP) \< 90 mmHg or \> 140 mmHg; diastolic blood pressure (DBP) \< 50 mmHg or \> 90 mmHg (using the mean of triplicate measurements) at Screening or admission. One re-test was allowed, if (a) test result(s) was outside these limits. 6. History of any clinically significant cardiac arrhythmia. Subject had a corrected QT interval using Fridericia's formula (QTcF) interval \> 450 msec or 2nd or 3rd degree atrioventricular (AV) block, high-grade sinoatrial block or PQ interval \> 0.24 seconds at Screening (using the mean of triplicate measurements). If a mean ECG parameter of a triplicate ECG exceeded the limits above, an additional triplicate ECG could have been taken. If this also gave an abnormal result, the subject was excluded. Also, the following cardiac conditions led to exclusion of the subjects: Untreated heart failure (pulmonary oedema, impaired blood flow or hypotension) and continuous or intermittent treatment leading to an increased contractility of the heart muscle (beta-receptor agonism); sick sinus syndrome; cardiogenic shock; severe peripheral arterial circulatory disturbances. 7. Had a creatinine value exceeding the ULN. 8. Subject had a positive test for hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (indicative of active hepatitis B), hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) type 1 and/or type 2 antibodies. 9. Use of any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to admission or 5 half-lives of the drug, whichever was longer, except for the occasional use of paracetamol (up to 2 g/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) and hormonal contraception for female subjects. 10. Subject had history of alcohol and/or illicit drug abuse within 2 years of entry. 11. Subject had positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids) or alcohol test at Screening or at admission. 12. History of drinking \> 168 g (males) and \> 84 g (females) pure alcohol per week (10 g pure alcohol = 259 mL of beer \[5%\] or 35 mL of spirits \[35%\] or 100 mL of wine \[12%\] within 3 months prior to admission to the clinical unit. 13. Subject consumed more than 600 mg caffeine per day (e.g., more than 3 cups of coffee containing 200 mg caffeine per cup) within the 4 weeks before admission or the subject was unwilling to avoid consumption of coffee and caffeine-containing beverages within 48 hours prior to admission until discharge from the clinical unit. 14. Subject was unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Screening and from admission until discharge from the clinical unit. 15. Any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days, or donated plasma within 7 days prior to the admission to the clinical unit. 16. Participation in any clinical study within 3 months or 5 half-lives of the drug, whichever was longer, prior to the expected date of IMP administration, or participation in more than 3 clinical studies within 12 months. 17. Subject with a relevant history or with a present psychiatric disorder, including depression, suicidal ideation, or eating disorders (e.g., bulimia or anorexia nervosa). Subjects with a medical history of relevant psychiatric disorders or known and relevant family history or evidence of anxiety disorders or depression as judged by the Investigator using the Generalized Anxiety Disorder Assessment-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) at Screening. Any of the following led to exclusion of the subject: * Subject had a GAD-7 mood scale score ≥ 10. * Subject had a score ≥ 10 on the PHQ-9 questionnaire. * Subject selected a response of 1, 2 or 3 to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9). 18. Use of any agent used for weight loss within the last 3 months. 19. More than 5% weight loss within the last 3 months. 20. Hypo- or hyperthyroidism. 21. Subject was pregnant or lactating. 22. Subject was unwilling to abstain from vigorous exercise from 48 hours prior to admission until discharge. 23. Subject had a history of hypersensitivity to the Investigational medicinal products (IMPs) or any of the excipients or to medicinal products with similar chemical structures. 24. Any contraindication for metoprolol, e.g., severe peripheral arterial disease, untreated pheochromocytoma, concomitant intravenous administration of calcium antagonists of verapamil and diltiazem, due to the risk of hypotension, atrioventricular (AV) conduction disturbances, or left ventricular insufficiency. 25. Subject had lactose intolerance or a rare hereditary problem of fructose intolerance, glucose galactose malabsorption or sucrase isomaltase insufficiency. 26. Subject was unable to understand and communicate in German language or to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study or was unlikely to comply with the study requirements; e.g., uncooperative attitude and improbability of completing the clinical study. 27. Subject had previously been enrolled in this clinical study. 28. Vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons in detention, minors and those incapable of giving consent). 29. Subject was the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study or employee of the Sponsor or Parexel. 30. Poor or ultra-rapid cytochrome P450 2D6 (CYP2D6) metabolizer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of Metoprolol Resulting in no Change in Mean Heart Rate Over 24 Hours (M24HR) | Day -1 to Day 23 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Baseline (Day -1), Days 14, 17, 20 and 23 | M24HR at Baseline (Day -1) and Days 14, 17, 20 and 23. |
| Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Days 15, 18, or 21 | M24HR following each of the 3 metoprolol doses (M24HR on Days 15, 18 or 21). |
| 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) | Baseline (Day -1), Day 14, Day 17, Day 20, Day 23 | Change in M24HR between pre-tesofensine baseline (Day -1) and after tesofensine alone (Day 14, Day 17, Day 20 and Day 23) |
| Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol | Day 15, Day 18, Day 21 | 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. |
| Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23) | Day 14, Day 17, Day 20 and Day 23 | Maximum and minimum heart rate of 24 hours (HRmax and HRmin) values after tesofensine alone (Day 14, Day 17, Day 20 and Day 23) |
| Maximum Heart Rate (HRmax) and Minimum Heart Rate (HRmin) Values After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21) | Day 15, Day 18, Day 21 | — |
| 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) | From 12 to 13 hours post-dose on Day 14, Day 17, Day 20 and Day 23 | — |
| 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) | From 12 to 13 hours post-dose on Day 15, Day 18, or Day 21 | — |
| 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) | Day -1, Day 13 [pre-dose only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23 | — |
| Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | 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. | — |
| Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21 | Day 15, Day 18 and Day 21 | — |
| Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Day 15, Day 18 and Day 21 | — |
| Area Under the Concentration-time Curve From 0 to 24 h (AUC 0-24) of Metoprolol on Day 15, Day 18, and Day 21 | Day 15, Day 18 and Day 21 | — |
| Heart Rate (HR) Stratified by Metoprolol Concentration | Day before dosing (Days 14, 17, 20), dosing day (Days 15, 18, 21) and two days after dosing (Days 17, 20, 23) | — |
| Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | From baseline to Day 23 | 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). |
| Mean of Triplicated QT Interval | Day -1, Day 13 [pre-dose only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23 | Mean of triplicated QT Interval |
| Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | 30 days prior to Screening until the Safety Follow-up phone call, up to Day 50 | Any medicinal product, prescribed or over-the-counter (OTC), including herbal and other non-traditional remedies, was considered a concomitant medication. |
| 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, Day 13 [pre-dose only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23 | — |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 16 |
| 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. | 12 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 | 2 |
| Overall Study | Other | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | Cohort 1 (Tesofensine 0.25mg) | Cohort 2 (Tesofensine 0.50mg) | Cohort 3 (Tesofensine 0.75mg) | Total |
|---|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 10.68 | 43.1 years STANDARD_DEVIATION 11.61 | 43.8 years STANDARD_DEVIATION 9.74 | 43.9 years STANDARD_DEVIATION 10.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 16 Participants | 12 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 174.1 cm STANDARD_DEVIATION 10.91 | 171.1 cm STANDARD_DEVIATION 9.84 | 170.1 cm STANDARD_DEVIATION 6.49 | 171.5 cm STANDARD_DEVIATION 9.06 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 16 Participants | 12 Participants | 37 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 5 Participants | 17 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 7 Participants | 20 Participants |
| Weight | 95.52 kg STANDARD_DEVIATION 11.602 | 88.56 kg STANDARD_DEVIATION 9.801 | 91.08 kg STANDARD_DEVIATION 10.925 | 91.07 kg STANDARD_DEVIATION 10.685 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 16 | 0 / 12 |
| other Total, other adverse events | 7 / 9 | 15 / 16 | 12 / 12 |
| serious Total, serious adverse events | 0 / 9 | 1 / 16 | 1 / 12 |
Outcome results
Primary
Dose of Metoprolol Resulting in no Change in Mean Heart Rate Over 24 Hours (M24HR)
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.
Time frame: Day -1 to Day 23
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | Dose of Metoprolol Resulting in no Change in Mean Heart Rate Over 24 Hours (M24HR) | 10.04 mg |
| Cohort 2 (Tesofensine 0.50mg) | Dose of Metoprolol Resulting in no Change in Mean Heart Rate Over 24 Hours (M24HR) | 60.95 mg |
| Cohort 3 (Tesofensine 0.75mg) | Dose of Metoprolol Resulting in no Change in Mean Heart Rate Over 24 Hours (M24HR) | 147.91 mg |
Secondary
Area Under the Concentration-time Curve From 0 to 24 h (AUC 0-24) of Metoprolol on Day 15, Day 18, and Day 21
Time frame: Day 15, Day 18 and Day 21
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 65.5 |
| Cohort 1 (Tesofensine 0.25mg) | 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 87.7 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 240.92 h*μg/L | Geometric Coefficient of Variation 58.21 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 105.41 h*μg/L | Geometric Coefficient of Variation 51.46 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 458.35 h*μg/L | Geometric Coefficient of Variation 52.06 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 104.90 h*μg/L | Geometric Coefficient of Variation 54.76 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 466.34 h*μg/L | Geometric Coefficient of Variation 45.85 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 221.59 h*μg/L | Geometric Coefficient of Variation 28.47 |
Secondary
Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose
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).
Time frame: From baseline to Day 23
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | Metoprolol 100 mg | -3.59 bpm |
| Cohort 1 (Tesofensine 0.25mg) | Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | Metoprolol 50 mg | -2.99 bpm |
| Cohort 1 (Tesofensine 0.25mg) | Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | Metoprolol 25 mg | -1.17 bpm |
| Cohort 2 (Tesofensine 0.50mg) | Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | Metoprolol 100 mg | -2.13 bpm |
| Cohort 2 (Tesofensine 0.50mg) | Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | Metoprolol 25 mg | 3.55 bpm |
| Cohort 2 (Tesofensine 0.50mg) | Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | Metoprolol 50 mg | 0.88 bpm |
| Cohort 3 (Tesofensine 0.75mg) | Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | Metoprolol 50 mg | 7.98 bpm |
| Cohort 3 (Tesofensine 0.75mg) | Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | Metoprolol 25 mg | 6.97 bpm |
| Cohort 3 (Tesofensine 0.75mg) | Change From Baseline Mean Heart Rate Over 24 Hours (M24HR) by Metoprolol Dose | Metoprolol 100 mg | 0.45 bpm |
Secondary
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 in M24HR between pre-tesofensine baseline (Day -1) and after tesofensine alone (Day 14, Day 17, Day 20 and Day 23)
Time frame: Baseline (Day -1), Day 14, Day 17, Day 20, Day 23
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 2.2 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 11.8 bpm | Standard Deviation 6.62 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 3.5 bpm | Standard Deviation 4.5 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 7.8 bpm | Standard Deviation 3.21 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 5.2 bpm | Standard Deviation 4.56 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 12.2 bpm | Standard Deviation 6.83 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 10.3 bpm | Standard Deviation 6.44 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 10.0 bpm | Standard Deviation 6.48 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 7.0 bpm | Standard Deviation 5.69 |
Secondary
Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol
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.
Time frame: Day 15, Day 18, Day 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol | Metoprolol 100 mg | -6.0 bpm | Standard Deviation 3.5 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol | Metoprolol 25 mg | -2.9 bpm | Standard Deviation 2.25 |
| Cohort 2 (Tesofensine 0.50mg) | Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol | Metoprolol 100 mg | -6.9 bpm | Standard Deviation 2.5 |
| Cohort 2 (Tesofensine 0.50mg) | Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol | Metoprolol 50 mg | -4.8 bpm | Standard Deviation 2.89 |
| Cohort 3 (Tesofensine 0.75mg) | Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol | Metoprolol 100 mg | -7.6 bpm | Standard Deviation 2.3 |
| Cohort 3 (Tesofensine 0.75mg) | Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol | Metoprolol 50 mg | -4.7 bpm | Standard Deviation 2.42 |
| Cohort 3 (Tesofensine 0.75mg) | Change in Mean Heart Rate Over 24 Hours (M24HR) Values After Tesofensine Co-administered With Metoprolol | Metoprolol 25 mg | -2.2 bpm | Standard Deviation 2.05 |
Secondary
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)
Time frame: Day -1, Day 13 [pre-dose only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 12.51 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 8.5 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 15.65 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 10.74 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 10.81 |
| Cohort 1 (Tesofensine 0.25mg) | 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 7.55 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 13.69 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 10.01 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 9.08 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 11.85 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 10.42 |
| Cohort 1 (Tesofensine 0.25mg) | 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 4.56 |
| Cohort 1 (Tesofensine 0.25mg) | 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 9.79 |
| Cohort 1 (Tesofensine 0.25mg) | 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 8.48 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 8.94 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 7.97 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 116.83 mm Hg | Standard Deviation 9.799 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 72.23 mm Hg | Standard Deviation 6.881 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 70.08 mm Hg | Standard Deviation 6.681 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.18 mm Hg | Standard Deviation 6.024 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 73.93 mm Hg | Standard Deviation 6.405 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 68.28 mm Hg | Standard Deviation 7.602 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.54 mm Hg | Standard Deviation 10.062 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.26 mm Hg | Standard Deviation 7.755 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 73.40 mm Hg | Standard Deviation 2.859 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 72.57 mm Hg | Standard Deviation 10.657 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 73.33 mm Hg | Standard Deviation 4.235 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 67.78 mm Hg | Standard Deviation 5.407 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 76.00 mm Hg | Standard Deviation 4.667 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.14 mm Hg | Standard Deviation 4.944 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 114.22 mm Hg | Standard Deviation 8.844 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 118.69 mm Hg | Standard Deviation 12.81 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 115.64 mm Hg | Standard Deviation 9.746 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 114.26 mm Hg | Standard Deviation 13.264 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 113.74 mm Hg | Standard Deviation 15.735 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 123.15 mm Hg | Standard Deviation 16.418 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 107.15 mm Hg | Standard Deviation 4.012 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.00 mm Hg | Standard Deviation 5.235 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 63.87 mm Hg | Standard Deviation 7.387 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 68.68 mm Hg | Standard Deviation 4.609 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 69.39 mm Hg | Standard Deviation 5.265 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 66.66 mm Hg | Standard Deviation 5.051 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.24 mm Hg | Standard Deviation 5.017 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.58 mm Hg | Standard Deviation 6.727 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 67.23 mm Hg | Standard Deviation 5.93 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 70.19 mm Hg | Standard Deviation 5.499 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 70.76 mm Hg | Standard Deviation 4.939 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 67.91 mm Hg | Standard Deviation 5.12 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 70.75 mm Hg | Standard Deviation 5.893 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 70.97 mm Hg | Standard Deviation 7.122 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 70.15 mm Hg | Standard Deviation 6.363 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 68.89 mm Hg | Standard Deviation 6.413 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 67.54 mm Hg | Standard Deviation 4.643 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 69.85 mm Hg | Standard Deviation 5.34 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 69.99 mm Hg | Standard Deviation 4.541 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.55 mm Hg | Standard Deviation 6.831 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 68.50 mm Hg | Standard Deviation 6.328 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.54 mm Hg | Standard Deviation 7.256 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 74.52 mm Hg | Standard Deviation 7.792 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 74.25 mm Hg | Standard Deviation 3.817 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 67.78 mm Hg | Standard Deviation 4.541 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 72.68 mm Hg | Standard Deviation 5.068 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 73.00 mm Hg | Standard Deviation 6.947 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 70.58 mm Hg | Standard Deviation 3.837 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.60 mm Hg | Standard Deviation 8.405 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 109.66 mm Hg | Standard Deviation 12.729 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 112.60 mm Hg | Standard Deviation 15.101 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 112.88 mm Hg | Standard Deviation 14.848 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 115.83 mm Hg | Standard Deviation 11.601 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 115.50 mm Hg | Standard Deviation 14.721 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 118.43 mm Hg | Standard Deviation 17.039 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 122.00 mm Hg | Standard Deviation 16.88 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 123.47 mm Hg | Standard Deviation 15.165 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 117.47 mm Hg | Standard Deviation 9.506 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 121.67 mm Hg | Standard Deviation 8.223 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 121.00 mm Hg | Standard Deviation 16.79 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 122.23 mm Hg | Standard Deviation 12.168 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 115.55 mm Hg | Standard Deviation 7.441 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 108.90 mm Hg | Standard Deviation 11.661 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 113.12 mm Hg | Standard Deviation 14.809 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 123.28 mm Hg | Standard Deviation 13.124 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 110.22 mm Hg | Standard Deviation 10.286 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 111.10 mm Hg | Standard Deviation 8.924 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 108.18 mm Hg | Standard Deviation 6.185 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 108.28 mm Hg | Standard Deviation 7.775 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 112.08 mm Hg | Standard Deviation 4.749 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.16 mm Hg | Standard Deviation 8.603 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 70.35 mm Hg | Standard Deviation 4.159 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 70.93 mm Hg | Standard Deviation 5.734 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 73.60 mm Hg | Standard Deviation 6.902 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.15 mm Hg | Standard Deviation 7.964 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 78.33 mm Hg | Standard Deviation 10.795 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.87 mm Hg | Standard Deviation 7.467 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 73.00 mm Hg | Standard Deviation 6.032 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 74.20 mm Hg | Standard Deviation 6.183 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.83 mm Hg | Standard Deviation 5.043 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 65.95 mm Hg | Standard Deviation 3.651 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.05 mm Hg | Standard Deviation 7.023 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 66.82 mm Hg | Standard Deviation 4.704 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 68.58 mm Hg | Standard Deviation 5.169 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 65.08 mm Hg | Standard Deviation 3.428 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 66.68 mm Hg | Standard Deviation 4.261 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 65.83 mm Hg | Standard Deviation 6.081 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 66.08 mm Hg | Standard Deviation 3.175 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.95 mm Hg | Standard Deviation 4.216 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 63.73 mm Hg | Standard Deviation 3.037 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 67.10 mm Hg | Standard Deviation 5.255 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 64.67 mm Hg | Standard Deviation 5.343 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 75.30 mm Hg | Standard Deviation 1.414 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 74.65 mm Hg | Standard Deviation 1.909 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.65 mm Hg | Standard Deviation 0.495 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 72.00 mm Hg | Standard Deviation 2.404 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 73.62 mm Hg | Standard Deviation 6.64 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 72.60 mm Hg | Standard Deviation 5.019 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 72.80 mm Hg | Standard Deviation 4.727 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.86 mm Hg | Standard Deviation 3.734 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 113.51 mm Hg | Standard Deviation 6.626 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 108.13 mm Hg | Standard Deviation 9.565 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 112.65 mm Hg | Standard Deviation 10.492 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 112.79 mm Hg | Standard Deviation 11.262 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 116.44 mm Hg | Standard Deviation 10.639 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 115.53 mm Hg | Standard Deviation 11.63 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 111.74 mm Hg | Standard Deviation 10.479 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 117.85 mm Hg | Standard Deviation 12.695 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 112.82 mm Hg | Standard Deviation 10.935 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 117.53 mm Hg | Standard Deviation 10.373 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 119.01 mm Hg | Standard Deviation 11.85 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 120.24 mm Hg | Standard Deviation 12.66 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 113.80 mm Hg | Standard Deviation 11.463 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 113.92 mm Hg | Standard Deviation 11.205 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 114.44 mm Hg | Standard Deviation 10.849 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 117.78 mm Hg | Standard Deviation 12.058 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 116.58 mm Hg | Standard Deviation 10.778 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 116.43 mm Hg | Standard Deviation 13.179 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 113.05 mm Hg | Standard Deviation 12.73 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 117.38 mm Hg | Standard Deviation 13.244 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 121.24 mm Hg | Standard Deviation 14.711 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 124.08 mm Hg | Standard Deviation 14.322 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 118.80 mm Hg | Standard Deviation 5.916 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 111.50 mm Hg | Standard Deviation 6.104 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 117.43 mm Hg | Standard Deviation 6.098 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 124.35 mm Hg | Standard Deviation 13.169 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 119.33 mm Hg | Standard Deviation 9.947 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 114.93 mm Hg | Standard Deviation 12.018 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 107.40 mm Hg | Standard Deviation 10.153 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 111.70 mm Hg | Standard Deviation 10.995 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 113.60 mm Hg | Standard Deviation 13.686 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 107.37 mm Hg | Standard Deviation 12.757 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 125.35 mm Hg | Standard Deviation 6.152 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 121.50 mm Hg | Standard Deviation 10.607 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 122.85 mm Hg | Standard Deviation 7.283 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 116.20 mm Hg | Standard Deviation 2.121 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 118.15 mm Hg | Standard Deviation 6.859 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 117.02 mm Hg | Standard Deviation 3.71 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 109.26 mm Hg | Standard Deviation 8.021 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 117.68 mm Hg | Standard Deviation 7.477 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 118.74 mm Hg | Standard Deviation 12.817 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 116.74 mm Hg | Standard Deviation 10.827 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 130.20 mm Hg | Standard Deviation 20.506 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 118.90 mm Hg | Standard Deviation 4.703 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 73.10 mm Hg | Standard Deviation 3.568 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 127.00 mm Hg | Standard Deviation 25.032 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 121.10 mm Hg | Standard Deviation 5.986 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 68.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 141.35 mm Hg | Standard Deviation 38.679 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 125.01 mm Hg | Standard Deviation 13.571 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 72.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 74.00 mm Hg | Standard Deviation 5.205 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 78.00 mm Hg | Standard Deviation 15.981 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 74.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 78.33 mm Hg | Standard Deviation 6.207 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 136.00 mm Hg | Standard Deviation 22.203 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 71.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 75.20 mm Hg | Standard Deviation 5.327 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 123.13 mm Hg | Standard Deviation 10.019 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 117.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 116.34 mm Hg | Standard Deviation 7.74 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 76.67 mm Hg | Standard Deviation 5.677 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 127.20 mm Hg | Standard Deviation 21.92 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 118.01 mm Hg | Standard Deviation 9.51 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 79.90 mm Hg | Standard Deviation 4.257 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 82.26 mm Hg | Standard Deviation 7.506 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 119.97 mm Hg | Standard Deviation 7.666 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 119.76 mm Hg | Standard Deviation 9.957 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 81.34 mm Hg | Standard Deviation 6.33 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 115.30 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 123.29 mm Hg | Standard Deviation 13.645 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 124.00 mm Hg | Standard Deviation 15.556 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 123.33 mm Hg | Standard Deviation 13.602 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.54 mm Hg | Standard Deviation 8.795 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 71.30 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 124.29 mm Hg | Standard Deviation 14.259 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 78.88 mm Hg | Standard Deviation 3.275 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 76.14 mm Hg | Standard Deviation 9.077 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 125.94 mm Hg | Standard Deviation 12.902 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 78.08 mm Hg | Standard Deviation 7.286 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 83.50 mm Hg | Standard Deviation 17.678 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 124.34 mm Hg | Standard Deviation 14.504 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 75.48 mm Hg | Standard Deviation 11.316 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 127.65 mm Hg | Standard Deviation 12.233 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 122.77 mm Hg | Standard Deviation 10.881 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 75.08 mm Hg | Standard Deviation 9.153 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 75.57 mm Hg | Standard Deviation 5.353 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 125.48 mm Hg | Standard Deviation 11.657 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 78.38 mm Hg | Standard Deviation 8.679 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 117.00 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 129.22 mm Hg | Standard Deviation 13.063 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 81.38 mm Hg | Standard Deviation 7.746 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 126.50 mm Hg | Standard Deviation 13.011 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 131.12 mm Hg | Standard Deviation 15.701 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 78.65 mm Hg | Standard Deviation 8.054 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 79.00 mm Hg | Standard Deviation 6.647 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 122.52 mm Hg | Standard Deviation 16.577 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 75.83 mm Hg | Standard Deviation 5.199 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 110.00 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 126.00 mm Hg | Standard Deviation 11.011 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 75.90 mm Hg | Standard Deviation 5.16 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 120.43 mm Hg | Standard Deviation 5.353 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 128.54 mm Hg | Standard Deviation 13.331 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 76.69 mm Hg | Standard Deviation 5.087 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 71.50 mm Hg | Standard Deviation 4.525 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 127.28 mm Hg | Standard Deviation 16.69 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.54 mm Hg | Standard Deviation 7.374 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 81.14 mm Hg | Standard Deviation 6.935 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 128.62 mm Hg | Standard Deviation 11.53 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 75.13 mm Hg | Standard Deviation 7.129 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 121.23 mm Hg | Standard Deviation 0.681 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 126.46 mm Hg | Standard Deviation 7.896 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.73 mm Hg | Standard Deviation 5.384 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 74.80 mm Hg | Standard Deviation 10.607 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 77.30 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 78.20 mm Hg | Standard Deviation 12.021 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 126.46 mm Hg | Standard Deviation 12.526 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 81.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 77.85 mm Hg | Standard Deviation 14.354 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.79 mm Hg | Standard Deviation 7.288 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 75.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 133.10 mm Hg | Standard Deviation 14.674 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.49 mm Hg | Standard Deviation 4.556 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 81.00 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 130.53 mm Hg | Standard Deviation 15.747 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 130.40 mm Hg | Standard Deviation 9.27 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 77.50 mm Hg | Standard Deviation 9.617 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 127.13 mm Hg | Standard Deviation 12.044 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 71.27 mm Hg | Standard Deviation 6.221 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 73.50 mm Hg | Standard Deviation 12.445 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 124.67 mm Hg | Standard Deviation 8.793 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 121.00 mm Hg | Standard Deviation 1.48 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 130.00 mm Hg | Standard Deviation 11.933 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 69.50 mm Hg | Standard Deviation 1.131 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 129.90 mm Hg | Standard Deviation 14.626 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 74.88 mm Hg | Standard Deviation 5.346 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 80.00 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 117.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 82.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 80.30 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 117.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 131.80 mm Hg | Standard Deviation 10.082 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 82.00 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 125.30 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 80.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 117.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 71.86 mm Hg | Standard Deviation 5.184 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 80.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 122.30 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 112.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 83.90 mm Hg | Standard Deviation 10.523 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 116.85 mm Hg | Standard Deviation 9.687 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 120.90 mm Hg | Standard Deviation 2.476 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 80.10 mm Hg | Standard Deviation 9.226 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 114.70 mm Hg | Standard Deviation 5.657 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 69.66 mm Hg | Standard Deviation 5.233 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 82.10 mm Hg | Standard Deviation 10.86 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 117.50 mm Hg | Standard Deviation 19.092 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 124.43 mm Hg | Standard Deviation 5.518 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 79.00 mm Hg | Standard Deviation 9.154 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 119.15 mm Hg | Standard Deviation 18.173 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 121.67 mm Hg | Standard Deviation 4.245 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 75.13 mm Hg | Standard Deviation 9.152 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 126.50 mm Hg | Standard Deviation 16.263 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 73.83 mm Hg | Standard Deviation 5.838 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 85.00 mm Hg | Standard Deviation 12.304 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 133.00 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 78.15 mm Hg | Standard Deviation 13.93 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 78.00 mm Hg | Standard Deviation 11.314 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 121.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 117.30 mm Hg | Standard Deviation 1 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 82.85 mm Hg | Standard Deviation 4.455 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 137.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 134.35 mm Hg | Standard Deviation 24.537 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 77.00 mm Hg | Standard Deviation 3.818 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 133.00 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.80 mm Hg | Standard Deviation 9.539 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 78.57 mm Hg | Standard Deviation 1.858 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 139.70 mm Hg | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 124.23 mm Hg | Standard Deviation 5.437 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 75.10 mm Hg | Standard Deviation 5.303 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 133.00 mm Hg | Standard Deviation 29.274 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 124.71 mm Hg | Standard Deviation 10.037 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 77.90 mm Hg | Standard Deviation 3.305 |
Secondary
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)
Time frame: Day -1, Day 13 [pre-dose only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 13.19 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 7.59 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 6.68 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 | — |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 4.8 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 67.17 bpm | Standard Deviation 7.909 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 77.33 bpm | Standard Deviation 8.98 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 73.88 bpm | Standard Deviation 10.252 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 55.73 bpm | Standard Deviation 4.057 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.40 bpm | Standard Deviation 6.557 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.33 bpm | Standard Deviation 13.126 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 62.83 bpm | Standard Deviation 6.737 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 68.83 bpm | Standard Deviation 5.611 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 68.28 bpm | Standard Deviation 3.52 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 59.97 bpm | Standard Deviation 3.989 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 61.88 bpm | Standard Deviation 10.818 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.66 bpm | Standard Deviation 11.33 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 61.66 bpm | Standard Deviation 11.039 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 68.06 bpm | Standard Deviation 9.87 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 63.14 bpm | Standard Deviation 7.703 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.65 bpm | Standard Deviation 8.236 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 65.71 bpm | Standard Deviation 8.705 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 65.38 bpm | Standard Deviation 7.077 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 68.17 bpm | Standard Deviation 6.511 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.48 bpm | Standard Deviation 8.783 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 63.98 bpm | Standard Deviation 6.973 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 70.11 bpm | Standard Deviation 8.787 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 69.03 bpm | Standard Deviation 9.568 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 69.76 bpm | Standard Deviation 9.156 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 72.65 bpm | Standard Deviation 9.286 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 67.46 bpm | Standard Deviation 7.148 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.81 bpm | Standard Deviation 7.052 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 67.85 bpm | Standard Deviation 6.367 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 69.58 bpm | Standard Deviation 9.254 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 73.61 bpm | Standard Deviation 6.739 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 67.86 bpm | Standard Deviation 7.128 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 75.92 bpm | Standard Deviation 7.602 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.79 bpm | Standard Deviation 8.061 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.41 bpm | Standard Deviation 7.26 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 76.69 bpm | Standard Deviation 8.385 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.69 bpm | Standard Deviation 11.467 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 73.53 bpm | Standard Deviation 12.354 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 77.75 bpm | Standard Deviation 10.73 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 59.48 bpm | Standard Deviation 2.873 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 63.18 bpm | Standard Deviation 3.767 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 58.23 bpm | Standard Deviation 1.776 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 60.85 bpm | Standard Deviation 4.615 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.40 bpm | Standard Deviation 9.612 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.78 bpm | Standard Deviation 4.462 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 73.14 bpm | Standard Deviation 8.564 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 76.80 bpm | Standard Deviation 8.243 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 76.90 bpm | Standard Deviation 3.344 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 80.00 bpm | Standard Deviation 5.17 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 73.23 bpm | Standard Deviation 2.165 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.40 bpm | Standard Deviation 4.723 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 74.23 bpm | Standard Deviation 3.015 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 70.47 bpm | Standard Deviation 6.353 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 74.00 bpm | Standard Deviation 5.568 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 67.47 bpm | Standard Deviation 4.895 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 69.10 bpm | Standard Deviation 7.136 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 74.33 bpm | Standard Deviation 3.953 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 71.72 bpm | Standard Deviation 7.843 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 64.50 bpm | Standard Deviation 7.223 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 61.88 bpm | Standard Deviation 6.462 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 64.38 bpm | Standard Deviation 6.019 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 65.25 bpm | Standard Deviation 7.722 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 64.75 bpm | Standard Deviation 8.048 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 67.00 bpm | Standard Deviation 8.922 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 65.18 bpm | Standard Deviation 6.649 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 68.35 bpm | Standard Deviation 10.394 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 65.65 bpm | Standard Deviation 9.405 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 61.00 bpm | Standard Deviation 8.061 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 58.35 bpm | Standard Deviation 8.98 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 62.30 bpm | Standard Deviation 2.828 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 67.08 bpm | Standard Deviation 8.499 |
| Cohort 2 (Tesofensine 0.50mg) | 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) | 60.66 bpm | Standard Deviation 9.142 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 56.70 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 74.70 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 75.43 bpm | Standard Deviation 6.394 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 71.90 bpm | Standard Deviation 3.483 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 74.85 bpm | Standard Deviation 0.212 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 72.80 bpm | Standard Deviation 8.155 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 74.33 bpm | Standard Deviation 8.736 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 75.15 bpm | Standard Deviation 6.859 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 79.18 bpm | Standard Deviation 10.04 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 63.70 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 70.85 bpm | Standard Deviation 0.212 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 72.49 bpm | Standard Deviation 6.267 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 78.77 bpm | Standard Deviation 3.044 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 66.70 bpm | Standard Deviation 1.414 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 80.17 bpm | Standard Deviation 9.304 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 66.10 bpm | Standard Deviation 10.198 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 71.20 bpm | Standard Deviation 4.95 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 73.49 bpm | Standard Deviation 7.267 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 75.68 bpm | Standard Deviation 8.004 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 88.70 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 72.03 bpm | Standard Deviation 9.966 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 65.80 bpm | Standard Deviation 7.778 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 100.00 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 72.53 bpm | Standard Deviation 8.269 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 71.70 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 90.30 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 70.01 bpm | Standard Deviation 7.574 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 65.23 bpm | Standard Deviation 3.233 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 79.70 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 74.11 bpm | Standard Deviation 7.645 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 79.50 bpm | Standard Deviation 17.253 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 86.30 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 71.08 bpm | Standard Deviation 9.917 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 56.00 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 81.67 bpm | Standard Deviation 16.359 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 79.20 bpm | Standard Deviation 10.613 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 65.93 bpm | Standard Deviation 7.195 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 71.33 bpm | Standard Deviation 9.292 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 71.67 bpm | Standard Deviation 10.855 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 66.87 bpm | Standard Deviation 8.109 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 74.33 bpm | Standard Deviation 6.987 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 73.10 bpm | Standard Deviation 7.045 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 73.67 bpm | Standard Deviation 5.677 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 78.13 bpm | Standard Deviation 8.79 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 79.53 bpm | Standard Deviation 7.012 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 82.00 bpm | Standard Deviation 9.3 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 68.15 bpm | Standard Deviation 8.697 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 97.20 bpm | Standard Deviation 27.577 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 74.28 bpm | Standard Deviation 4.754 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 65.15 bpm | Standard Deviation 6.859 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 83.65 bpm | Standard Deviation 10.819 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 80.50 bpm | Standard Deviation 14.425 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 73.90 bpm | Standard Deviation 8.044 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 70.18 bpm | Standard Deviation 9.287 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 82.85 bpm | Standard Deviation 12.516 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 81.60 bpm | Standard Deviation 12.056 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 78.92 bpm | Standard Deviation 5.821 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 87.00 bpm | Standard Deviation 6.081 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 74.08 bpm | Standard Deviation 10.559 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 71.50 bpm | Standard Deviation 10.182 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 72.00 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 73.86 bpm | Standard Deviation 9.38 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 65.71 bpm | Standard Deviation 7.051 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 68.70 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.66 bpm | Standard Deviation 9.39 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 76.00 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 70.70 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 75.48 bpm | Standard Deviation 12.388 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 73.74 bpm | Standard Deviation 3.356 |
| Cohort 3 (Tesofensine 0.75mg) | 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) | 64.00 bpm | — |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 84.45 bpm | Standard Deviation 13.229 |
Secondary
Heart Rate (HR) Stratified by Metoprolol Concentration
Time frame: Day before dosing (Days 14, 17, 20), dosing day (Days 15, 18, 21) and two days after dosing (Days 17, 20, 23)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 100 mg; Day before dosing | 75.2 bpm | Standard Deviation 9.3 |
| Cohort 1 (Tesofensine 0.25mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 50 mg; Day before dosing | 74.3 bpm | Standard Deviation 9.62 |
| Cohort 1 (Tesofensine 0.25mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 25 mg; Dosing day | 71.1 bpm | Standard Deviation 9.45 |
| Cohort 1 (Tesofensine 0.25mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 50 mg; Two days after dosing | 76.2 bpm | Standard Deviation 10.06 |
| Cohort 1 (Tesofensine 0.25mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 50 mg; Dosing day | 69.6 bpm | Standard Deviation 9.4 |
| Cohort 1 (Tesofensine 0.25mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 25 mg; Day before dosing | 73.8 bpm | Standard Deviation 9.96 |
| Cohort 1 (Tesofensine 0.25mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 100 mg; Dosing day | 69.2 bpm | Standard Deviation 9.46 |
| Cohort 1 (Tesofensine 0.25mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 25 mg; Two days after dosing | 76.8 bpm | Standard Deviation 10.94 |
| Cohort 1 (Tesofensine 0.25mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 100 mg; Two days after dosing | 76.6 bpm | Standard Deviation 10.13 |
| Cohort 2 (Tesofensine 0.50mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 100 mg; Two days after dosing | 78.8 bpm | Standard Deviation 4.26 |
| Cohort 2 (Tesofensine 0.50mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 25 mg; Day before dosing | 79.4 bpm | Standard Deviation 8.13 |
| Cohort 2 (Tesofensine 0.50mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 25 mg; Dosing day | 76.5 bpm | Standard Deviation 7.68 |
| Cohort 2 (Tesofensine 0.50mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 25 mg; Two days after dosing | 82.1 bpm | Standard Deviation 8.88 |
| Cohort 2 (Tesofensine 0.50mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 50 mg; Day before dosing | 78.7 bpm | Standard Deviation 5.47 |
| Cohort 2 (Tesofensine 0.50mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 50 mg; Dosing day | 73.9 bpm | Standard Deviation 5.75 |
| Cohort 2 (Tesofensine 0.50mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 50 mg; Two days after dosing | 82.1 bpm | Standard Deviation 7.22 |
| Cohort 2 (Tesofensine 0.50mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 100 mg; Day before dosing | 77.6 bpm | Standard Deviation 5.47 |
| Cohort 2 (Tesofensine 0.50mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 100 mg; Dosing day | 70.7 bpm | Standard Deviation 6.05 |
| Cohort 3 (Tesofensine 0.75mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 50 mg; Two days after dosing | 83.0 bpm | Standard Deviation 7.11 |
| Cohort 3 (Tesofensine 0.75mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 25 mg; Two days after dosing | 85.7 bpm | Standard Deviation 7.47 |
| Cohort 3 (Tesofensine 0.75mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 25 mg; Day before dosing | 82.2 bpm | Standard Deviation 7.41 |
| Cohort 3 (Tesofensine 0.75mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 100 mg; Day before dosing | 81.2 bpm | Standard Deviation 5.26 |
| Cohort 3 (Tesofensine 0.75mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 25 mg; Dosing day | 80.0 bpm | Standard Deviation 7.71 |
| Cohort 3 (Tesofensine 0.75mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 100 mg; Two days after dosing | 84.4 bpm | Standard Deviation 8.91 |
| Cohort 3 (Tesofensine 0.75mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 50 mg; Dosing day | 80.8 bpm | Standard Deviation 7.83 |
| Cohort 3 (Tesofensine 0.75mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 50 mg; Day before dosing | 85.5 bpm | Standard Deviation 7.92 |
| Cohort 3 (Tesofensine 0.75mg) | Heart Rate (HR) Stratified by Metoprolol Concentration | Metoprolol 100 mg; Dosing day | 73.6 bpm | Standard Deviation 3.91 |
Secondary
Maximum and Minimum Heart Rate of 24 Hours (HRmax and HRmin) Values After Tesofensine Alone (Day 14, Day 17, Day 20 and Day 23)
Maximum and minimum heart rate of 24 hours (HRmax and HRmin) values after tesofensine alone (Day 14, Day 17, Day 20 and Day 23)
Time frame: Day 14, Day 17, Day 20 and Day 23
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 7.6 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 59.7 bpm | Standard Deviation 5.69 |
| Cohort 2 (Tesofensine 0.50mg) | 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; | 125.2 bpm | Standard Deviation 12.21 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 117.5 bpm | Standard Deviation 10.43 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 124.6 bpm | Standard Deviation 11.57 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 134.5 bpm | Standard Deviation 12.77 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 56.7 bpm | Standard Deviation 5.78 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 58.5 bpm | Standard Deviation 4.86 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 58.9 bpm | Standard Deviation 5.53 |
| Cohort 3 (Tesofensine 0.75mg) | 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; | 131.0 bpm | Standard Deviation 20.36 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 124.2 bpm | Standard Deviation 17.79 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 60.2 bpm | Standard Deviation 6.74 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 126.2 bpm | Standard Deviation 17.63 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 61.6 bpm | Standard Deviation 6.11 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 133.6 bpm | Standard Deviation 17.97 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 60.6 bpm | Standard Deviation 6.95 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 59.5 bpm | Standard Deviation 4.42 |
Secondary
Maximum Heart Rate (HRmax) and Minimum Heart Rate (HRmin) Values After Tesofensine Co-administered With Metoprolol (Day 15, Day 18 and Day 21)
Time frame: Day 15, Day 18, Day 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 19.9 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 55.9 bpm | Standard Deviation 4.65 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 56.7 bpm | Standard Deviation 5.89 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 118.5 bpm | Standard Deviation 10.24 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 52.9 bpm | Standard Deviation 4.66 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 117.8 bpm | Standard Deviation 14.32 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 111.9 bpm | Standard Deviation 9.42 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 55.7 bpm | Standard Deviation 5.43 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 114.0 bpm | Standard Deviation 12.27 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 57.4 bpm | Standard Deviation 3.51 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 55.6 bpm | Standard Deviation 4.56 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 120.0 bpm | Standard Deviation 11.73 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 125.0 bpm | Standard Deviation 14.14 |
Secondary
Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21
Time frame: Day 15, Day 18 and Day 21
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 100 mg | 25.83 μg/L | Geometric Coefficient of Variation 46.79 |
| Cohort 2 (Tesofensine 0.50mg) | Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 25 mg | 6.402 μg/L | Geometric Coefficient of Variation 49.71 |
| Cohort 2 (Tesofensine 0.50mg) | Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 50 mg | 14.91 μg/L | Geometric Coefficient of Variation 54.3 |
| Cohort 3 (Tesofensine 0.75mg) | Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 100 mg | 27.59 μg/L | Geometric Coefficient of Variation 51.38 |
| Cohort 3 (Tesofensine 0.75mg) | Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 50 mg | 13.25 μg/L | Geometric Coefficient of Variation 32.13 |
| Cohort 3 (Tesofensine 0.75mg) | Maximum Serum Concentration (Cmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 25 mg | 6.009 μg/L | Geometric Coefficient of Variation 45.95 |
Secondary
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)
Time frame: From 12 to 13 hours post-dose on Day 14, Day 17, Day 20 and Day 23
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 75.8 bpm | Standard Deviation 8.33 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 71.4 bpm | Standard Deviation 9.52 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 72.9 bpm | Standard Deviation 7.45 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 76.8 bpm | Standard Deviation 10.63 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 80.3 bpm | Standard Deviation 11.48 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.8 bpm | Standard Deviation 8.38 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.8 bpm | Standard Deviation 10.5 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.8 bpm | Standard Deviation 7.4 |
Secondary
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)
Time frame: From 12 to 13 hours post-dose on Day 15, Day 18, or Day 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 10.2 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 68.8 bpm | Standard Deviation 7.91 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 70.5 bpm | Standard Deviation 8.75 |
| Cohort 2 (Tesofensine 0.50mg) | 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 | 65.6 bpm | Standard Deviation 8.14 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 77.6 bpm | Standard Deviation 9.21 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 68.4 bpm | Standard Deviation 7.33 |
| Cohort 3 (Tesofensine 0.75mg) | 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 | 74.2 bpm | Standard Deviation 10.19 |
Secondary
Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23
M24HR at Baseline (Day -1) and Days 14, 17, 20 and 23.
Time frame: Baseline (Day -1), Days 14, 17, 20 and 23
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Day 17 | 78.2 bpm | Standard Deviation 5.85 |
| Cohort 2 (Tesofensine 0.50mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Baseline | 73.1 bpm | Standard Deviation 5.48 |
| Cohort 2 (Tesofensine 0.50mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Day 14 | 76.5 bpm | Standard Deviation 6.98 |
| Cohort 2 (Tesofensine 0.50mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Day 20 | 80.9 bpm | Standard Deviation 5.84 |
| Cohort 2 (Tesofensine 0.50mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Day 23 | 84.3 bpm | Standard Deviation 8.59 |
| Cohort 3 (Tesofensine 0.75mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Day 23 | 85.4 bpm | Standard Deviation 7.16 |
| Cohort 3 (Tesofensine 0.75mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Day 20 | 83.2 bpm | Standard Deviation 7.98 |
| Cohort 3 (Tesofensine 0.75mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Baseline | 74.3 bpm | Standard Deviation 5.82 |
| Cohort 3 (Tesofensine 0.75mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Day 17 | 84.7 bpm | Standard Deviation 8.31 |
| Cohort 3 (Tesofensine 0.75mg) | Mean Heart Rate Over 24 Hours (M24HR) at Baseline (Day -1) and Days 14, 17, 20 and 23 | Day 14 | 81.3 bpm | Standard Deviation 4.97 |
Secondary
Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21
M24HR following each of the 3 metoprolol doses (M24HR on Days 15, 18 or 21).
Time frame: Days 15, 18, or 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Metoprolol 50 mg | 69.6 bpm | Standard Deviation 9.4 |
| Cohort 1 (Tesofensine 0.25mg) | Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Metoprolol 25 mg | 71.1 bpm | Standard Deviation 9.45 |
| Cohort 1 (Tesofensine 0.25mg) | Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Metoprolol 100 mg | 69.2 bpm | Standard Deviation 9.46 |
| Cohort 2 (Tesofensine 0.50mg) | Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Metoprolol 50 mg | 73.9 bpm | Standard Deviation 5.75 |
| Cohort 2 (Tesofensine 0.50mg) | Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Metoprolol 25 mg | 76.5 bpm | Standard Deviation 7.68 |
| Cohort 2 (Tesofensine 0.50mg) | Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Metoprolol 100 mg | 70.7 bpm | Standard Deviation 6.05 |
| Cohort 3 (Tesofensine 0.75mg) | Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Metoprolol 25 mg | 80.0 bpm | Standard Deviation 7.71 |
| Cohort 3 (Tesofensine 0.75mg) | Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Metoprolol 100 mg | 73.6 bpm | Standard Deviation 3.91 |
| Cohort 3 (Tesofensine 0.75mg) | Mean Heart Rate Over 24 Hours (M24HR) on Days 15, 18 or 21 | Metoprolol 50 mg | 80.8 bpm | Standard Deviation 7.83 |
Secondary
Mean of Triplicated QT Interval
Mean of triplicated QT Interval
Time frame: Day -1, Day 13 [pre-dose only], Day 14, Day 15, Day 17, Day 18, Day 20, Day 21 and Day 23
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/8h postdose (metop. 50 mg) | 419.30 msec | Standard Deviation 19.287 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/4h postdose (metop. 50 mg) | 396.87 msec | Standard Deviation 39.405 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 20/12h postdose | 382.29 msec | Standard Deviation 35.547 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/4h postdose (metop. 100 mg) | 380.70 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/2h postdose (metop. 50 mg) | 386.67 msec | Standard Deviation 34.141 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 23/predose | 403.10 msec | Standard Deviation 25.565 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day -1/12h postdose | 378.00 msec | Standard Deviation 26.099 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day -1/predose | 400.00 msec | Standard Deviation 23.654 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 23/2h postdose | 385.78 msec | Standard Deviation 24.461 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/2h postdose (metop. 25 mg) | 394.94 msec | Standard Deviation 16.701 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/predose (metop. 50 mg) | 408.20 msec | Standard Deviation 29.36 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 23/4h postdose | 394.16 msec | Standard Deviation 31.839 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/12h postdose (metop. 100 mg) | 414.43 msec | Standard Deviation 5.954 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/12h postdose (metop. 25 mg) | 372.70 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 23/8h postdose | 388.30 msec | Standard Deviation 28.021 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 13/predose | 404.14 msec | Standard Deviation 24.739 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/8h postdose (metop. 25 mg) | 386.00 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 23/12h postdose | 376.07 msec | Standard Deviation 22.251 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/4h postdose (metop. 100 mg) | 400.78 msec | Standard Deviation 38.353 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/4h postdose (metop. 25 mg) | 358.70 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/predose (metop. 25 mg) | 403.10 msec | Standard Deviation 24.701 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/8h postdose (metop. 100 mg) | 419.33 msec | Standard Deviation 10.081 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/2h postdose (metop. 25 mg) | 376.70 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/2h postdose (metop. 25 mg) | 376.23 msec | Standard Deviation 31.405 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 14/predose | 402.81 msec | Standard Deviation 28.425 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/predose (metop. 25 mg) | 368.70 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/4h postdose (metop. 25 mg) | 392.20 msec | Standard Deviation 32.336 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/12h postdose (metop. 50 mg) | 407.80 msec | Standard Deviation 1.559 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/12h postdose (metop. 25 mg) | 401.06 msec | Standard Deviation 17.177 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/8h postdose (metop. 25 mg) | 399.33 msec | Standard Deviation 36.382 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/4h postdose (metop. 100 mg) | 419.77 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/8h postdose (metop. 25 mg) | 411.86 msec | Standard Deviation 16.278 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/12h postdose (metop. 25 mg) | 396.43 msec | Standard Deviation 51.651 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 14/2h postdose | 392.37 msec | Standard Deviation 30.65 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/predose (metop. 25 mg) | 405.48 msec | Standard Deviation 26.341 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/predose (metop. 100 mg) | 389.30 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/2h postdose (metop. 100 mg) | 387.10 msec | Standard Deviation 13.146 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 14/4h postdose | 398.01 msec | Standard Deviation 30.117 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/12h postdose (metop. 100 mg) | 393.48 msec | Standard Deviation 38.721 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/predose (metop. 100 mg) | 381.10 msec | Standard Deviation 12.842 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 14/8h postdose | 396.82 msec | Standard Deviation 30.306 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/2h postdose (metop. 100 mg) | 383.60 msec | Standard Deviation 37.938 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/4h postdose (metop. 50 mg) | 402.87 msec | Standard Deviation 15.658 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 14/12h postdose | 386.01 msec | Standard Deviation 28.991 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/2h postdose (metop. 100 mg) | 371.30 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/2h postdose (metop. 50 mg) | 391.57 msec | Standard Deviation 7.769 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 17/predose | 405.10 msec | Standard Deviation 29.008 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/predose (metop. 100 mg) | 406.80 msec | Standard Deviation 39.537 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/predose (metop. 50 mg) | 406.43 msec | Standard Deviation 13.952 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 17/2h postdose | 391.99 msec | Standard Deviation 31.469 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day -1/2h postdose | 381.83 msec | Standard Deviation 20.867 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/12h postdose (metop. 50 mg) | 399.77 msec | Standard Deviation 45.018 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 17/4h postdose | 400.02 msec | Standard Deviation 29.034 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 21/8h postdose (metop. 100 mg) | 410.94 msec | Standard Deviation 38.128 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/8h postdose (metop. 50 mg) | 406.20 msec | Standard Deviation 40.115 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 17/8h postdose | 393.98 msec | Standard Deviation 25.616 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/12h postdose (metop. 100 mg) | 369.30 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/4h postdose (metop. 50 mg) | 410.03 msec | Standard Deviation 45.622 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 17/12h postdose | 378.51 msec | Standard Deviation 27.115 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day -1/4h postdose | 388.29 msec | Standard Deviation 27.746 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/2h postdose (metop. 50 mg) | 387.13 msec | Standard Deviation 41.727 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 20/predose | 407.56 msec | Standard Deviation 28.115 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/4h postdose (metop. 25 mg) | 412.14 msec | Standard Deviation 22.65 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/predose (metop. 50 mg) | 396.20 msec | Standard Deviation 30.513 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 20/2h postdose | 390.23 msec | Standard Deviation 31.513 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 18/8h postdose (metop. 100 mg) | 386.00 msec | — |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/12h postdose (metop. 50 mg) | 392.63 msec | Standard Deviation 29.143 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 20/4h postdose | 403.62 msec | Standard Deviation 31.402 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day -1/8h postdose | 395.78 msec | Standard Deviation 22.869 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 15/8h postdose (metop. 50 mg) | 405.57 msec | Standard Deviation 25.408 |
| Cohort 1 (Tesofensine 0.25mg) | Mean of Triplicated QT Interval | Day 20/8h postdose | 398.67 msec | Standard Deviation 33.745 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/predose (metop. 50 mg) | 388.67 msec | Standard Deviation 17.402 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day -1/predose | 398.08 msec | Standard Deviation 22.518 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/2h postdose (metop. 25 mg) | 384.52 msec | Standard Deviation 10.925 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/8h postdose (metop. 50 mg) | 404.48 msec | Standard Deviation 14.866 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/predose (metop. 100 mg) | 391.00 msec | Standard Deviation 15.556 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day -1/2h postdose | 375.76 msec | Standard Deviation 15.028 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day -1/4h postdose | 385.91 msec | Standard Deviation 14.718 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day -1/8h postdose | 391.67 msec | Standard Deviation 16.588 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day -1/12h postdose | 385.30 msec | Standard Deviation 16.044 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 13/predose | 384.81 msec | Standard Deviation 13.394 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 14/predose | 396.81 msec | Standard Deviation 13.317 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 14/2h postdose | 386.39 msec | Standard Deviation 18.472 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 14/4h postdose | 385.48 msec | Standard Deviation 14.826 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 14/8h postdose | 386.01 msec | Standard Deviation 16.595 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 14/12h postdose | 379.14 msec | Standard Deviation 17.101 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 17/predose | 392.72 msec | Standard Deviation 19.161 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 17/2h postdose | 377.69 msec | Standard Deviation 14.665 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 17/4h postdose | 390.76 msec | Standard Deviation 16.704 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 17/8h postdose | 384.11 msec | Standard Deviation 17.812 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 17/12h postdose | 374.83 msec | Standard Deviation 10.381 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 20/predose | 390.52 msec | Standard Deviation 16.942 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 20/2h postdose | 374.25 msec | Standard Deviation 13.47 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 20/4h postdose | 384.93 msec | Standard Deviation 15.006 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 20/8h postdose | 381.07 msec | Standard Deviation 13.22 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 20/12h postdose | 368.41 msec | Standard Deviation 14.193 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 23/predose | 382.83 msec | Standard Deviation 19.77 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 23/2h postdose | 371.06 msec | Standard Deviation 14.921 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 23/4h postdose | 378.17 msec | Standard Deviation 19.816 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 23/8h postdose | 375.13 msec | Standard Deviation 21.611 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 23/12h postdose | 365.06 msec | Standard Deviation 19.474 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/predose (metop. 25 mg) | 395.35 msec | Standard Deviation 5.735 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/2h postdose (metop. 25 mg) | 384.83 msec | Standard Deviation 7.265 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/4h postdose (metop. 25 mg) | 396.15 msec | Standard Deviation 9.293 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/8h postdose (metop. 25 mg) | 397.18 msec | Standard Deviation 15.108 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/12h postdose (metop. 25 mg) | 392.33 msec | Standard Deviation 12.747 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/predose (metop. 25 mg) | 396.12 msec | Standard Deviation 15.396 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/4h postdose (metop. 25 mg) | 399.46 msec | Standard Deviation 17.58 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/8h postdose (metop. 25 mg) | 389.48 msec | Standard Deviation 15.161 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/12h postdose (metop. 25 mg) | 378.94 msec | Standard Deviation 16.214 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/predose (metop. 25 mg) | 370.15 msec | Standard Deviation 13.164 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/2h postdose (metop. 25 mg) | 358.68 msec | Standard Deviation 12.613 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/4h postdose (metop. 25 mg) | 372.48 msec | Standard Deviation 8.33 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/8h postdose (metop. 25 mg) | 381.35 msec | Standard Deviation 18.034 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/12h postdose (metop. 25 mg) | 374.18 msec | Standard Deviation 12.217 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/2h postdose (metop. 50 mg) | 373.77 msec | Standard Deviation 15.187 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/4h postdose (metop. 50 mg) | 393.80 msec | Standard Deviation 12.387 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/8h postdose (metop. 50 mg) | 390.47 msec | Standard Deviation 3.281 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/12h postdose (metop. 50 mg) | 383.53 msec | Standard Deviation 0.404 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/predose (metop. 50 mg) | 385.75 msec | Standard Deviation 18.862 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/2h postdose (metop. 50 mg) | 377.53 msec | Standard Deviation 7.314 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/4h postdose (metop. 50 mg) | 390.88 msec | Standard Deviation 16.413 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/8h postdose (metop. 50 mg) | 400.00 msec | Standard Deviation 27.45 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/12h postdose (metop. 50 mg) | 388.57 msec | Standard Deviation 19.421 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/predose (metop. 50 mg) | 388.98 msec | Standard Deviation 15.647 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/2h postdose (metop. 50 mg) | 377.18 msec | Standard Deviation 22.436 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/4h postdose (metop. 50 mg) | 394.68 msec | Standard Deviation 21.586 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/12h postdose (metop. 50 mg) | 391.03 msec | Standard Deviation 18.953 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/predose (metop. 100 mg) | 391.55 msec | Standard Deviation 16.914 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/2h postdose (metop. 100 mg) | 382.22 msec | Standard Deviation 10.369 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/4h postdose (metop. 100 mg) | 406.12 msec | Standard Deviation 17.056 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/8h postdose (metop. 100 mg) | 400.45 msec | Standard Deviation 27.301 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 15/12h postdose (metop. 100 mg) | 396.68 msec | Standard Deviation 14.125 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/2h postdose (metop. 100 mg) | 375.00 msec | Standard Deviation 14.566 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/4h postdose (metop. 100 mg) | 392.65 msec | Standard Deviation 20.718 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/8h postdose (metop. 100 mg) | 405.00 msec | Standard Deviation 21.213 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 18/12h postdose (metop. 100 mg) | 393.00 msec | Standard Deviation 7.071 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/predose (metop. 100 mg) | 387.20 msec | Standard Deviation 14.916 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/2h postdose (metop. 100 mg) | 374.78 msec | Standard Deviation 16.698 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/4h postdose (metop. 100 mg) | 396.24 msec | Standard Deviation 17.208 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/8h postdose (metop. 100 mg) | 399.74 msec | Standard Deviation 24.355 |
| Cohort 2 (Tesofensine 0.50mg) | Mean of Triplicated QT Interval | Day 21/12h postdose (metop. 100 mg) | 387.60 msec | Standard Deviation 16.03 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/8h postdose (metop. 50 mg) | 393.00 msec | Standard Deviation 21.213 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 20/2h postdose | 376.68 msec | Standard Deviation 11.908 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day -1/8h postdose | 395.12 msec | Standard Deviation 19.83 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/12h postdose (metop. 50 mg) | 378.00 msec | Standard Deviation 2.828 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 20/predose | 389.34 msec | Standard Deviation 16.182 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/predose (metop. 25 mg) | 363.35 msec | Standard Deviation 29.204 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/predose (metop. 50 mg) | 381.30 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 17/12h postdose | 368.33 msec | Standard Deviation 11.941 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/4h postdose (metop. 100 mg) | 391.53 msec | Standard Deviation 16.762 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/2h postdose (metop. 50 mg) | 346.70 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 17/8h postdose | 382.00 msec | Standard Deviation 9.674 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day -1/4h postdose | 396.34 msec | Standard Deviation 28.389 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/4h postdose (metop. 50 mg) | 358.00 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 17/4h postdose | 382.88 msec | Standard Deviation 10.457 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/4h postdose (metop. 100 mg) | 428.70 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/8h postdose (metop. 50 mg) | 396.00 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 17/2h postdose | 371.45 msec | Standard Deviation 14.113 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/8h postdose (metop. 100 mg) | 392.87 msec | Standard Deviation 18.329 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/12h postdose (metop. 50 mg) | 374.70 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 17/predose | 393.53 msec | Standard Deviation 16.439 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day -1/2h postdose | 386.66 msec | Standard Deviation 30.168 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/predose (metop. 50 mg) | 378.43 msec | Standard Deviation 37.456 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 14/12h postdose | 375.43 msec | Standard Deviation 19.292 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/2h postdose (metop. 25 mg) | 381.35 msec | Standard Deviation 27.365 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/2h postdose (metop. 50 mg) | 371.57 msec | Standard Deviation 20.096 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 14/8h postdose | 389.64 msec | Standard Deviation 16.19 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/12h postdose (metop. 100 mg) | 382.87 msec | Standard Deviation 20.429 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/4h postdose (metop. 50 mg) | 388.90 msec | Standard Deviation 26.117 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day -1/predose | 404.28 msec | Standard Deviation 31.567 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/12h postdose (metop. 50 mg) | 379.10 msec | Standard Deviation 22.06 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 14/4h postdose | 389.43 msec | Standard Deviation 18.661 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/12h postdose (metop. 100 mg) | 402.00 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/predose (metop. 100 mg) | 397.65 msec | Standard Deviation 44.76 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 14/2h postdose | 383.24 msec | Standard Deviation 18.341 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/predose (metop. 100 mg) | 390.70 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/12h postdose (metop. 25 mg) | 378.20 msec | Standard Deviation 14.901 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/2h postdose (metop. 100 mg) | 388.65 msec | Standard Deviation 15.061 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 14/predose | 398.19 msec | Standard Deviation 16.649 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/4h postdose (metop. 25 mg) | 386.00 msec | Standard Deviation 29.274 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/8h postdose (metop. 25 mg) | 388.67 msec | Standard Deviation 13.785 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/predose (metop. 100 mg) | 380.90 msec | Standard Deviation 16.536 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/8h postdose (metop. 25 mg) | 378.30 msec | Standard Deviation 35.355 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/4h postdose (metop. 25 mg) | 384.23 msec | Standard Deviation 7.125 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/4h postdose (metop. 100 mg) | 406.65 msec | Standard Deviation 24.537 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/12h postdose (metop. 25 mg) | 364.65 msec | Standard Deviation 12.233 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/2h postdose (metop. 25 mg) | 374.67 msec | Standard Deviation 9.82 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 13/predose | 390.59 msec | Standard Deviation 19.371 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/predose (metop. 25 mg) | 384.00 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/predose (metop. 25 mg) | 384.00 msec | Standard Deviation 7.436 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/8h postdose (metop. 100 mg) | 428.70 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/2h postdose (metop. 25 mg) | 375.30 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 23/12h postdose | 371.62 msec | Standard Deviation 18.763 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/8h postdose (metop. 100 mg) | 414.65 msec | Standard Deviation 10.394 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/4h postdose (metop. 25 mg) | 376.70 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 23/8h postdose | 381.86 msec | Standard Deviation 19.204 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day -1/12h postdose | 387.56 msec | Standard Deviation 28.855 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/8h postdose (metop. 25 mg) | 395.30 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 23/4h postdose | 386.14 msec | Standard Deviation 24.694 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/2h postdose (metop. 100 mg) | 410.70 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/12h postdose (metop. 25 mg) | 366.00 msec | — |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 23/2h postdose | 369.74 msec | Standard Deviation 18.183 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 23/predose | 387.76 msec | Standard Deviation 20.46 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/predose (metop. 50 mg) | 372.30 msec | Standard Deviation 18.385 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 20/12h postdose | 377.08 msec | Standard Deviation 17.626 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/12h postdose (metop. 100 mg) | 398.00 msec | Standard Deviation 18.809 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/2h postdose (metop. 50 mg) | 380.35 msec | Standard Deviation 36.275 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 20/8h postdose | 392.26 msec | Standard Deviation 23.255 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 21/8h postdose (metop. 50 mg) | 388.23 msec | Standard Deviation 22.649 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 15/4h postdose (metop. 50 mg) | 375.00 msec | Standard Deviation 38.184 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 20/4h postdose | 385.20 msec | Standard Deviation 22.302 |
| Cohort 3 (Tesofensine 0.75mg) | Mean of Triplicated QT Interval | Day 18/2h postdose (metop. 100 mg) | 374.00 msec | Standard Deviation 14.117 |
Secondary
Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21
Time frame: Day 15, Day 18 and Day 21
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 25 mg | 12.0 hours |
| Cohort 1 (Tesofensine 0.25mg) | Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 50 mg | 7.98 hours |
| Cohort 1 (Tesofensine 0.25mg) | Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 100 mg | 4.02 hours |
| Cohort 2 (Tesofensine 0.50mg) | Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 100 mg | 8.00 hours |
| Cohort 2 (Tesofensine 0.50mg) | Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 50 mg | 8.02 hours |
| Cohort 2 (Tesofensine 0.50mg) | Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 25 mg | 8.03 hours |
| Cohort 3 (Tesofensine 0.75mg) | Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 25 mg | 9.98 hours |
| Cohort 3 (Tesofensine 0.75mg) | Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 50 mg | 10.2 hours |
| Cohort 3 (Tesofensine 0.75mg) | Time to Cmax (Tmax) of Metoprolol on Day 15, Day 18, and Day 21 | Metoprolol 100 mg | 8.04 hours |
Secondary
Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 1 (Tesofensine 0.25mg) | 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 |
| Cohort 2 (Tesofensine 0.50mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Day 23; | 8.569 ng/mL | Geometric Coefficient of Variation 35.4 |
| Cohort 2 (Tesofensine 0.50mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Metoprolol 50 mg | 7.940 ng/mL | Geometric Coefficient of Variation 37.85 |
| Cohort 2 (Tesofensine 0.50mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Metoprolol 25 mg | 7.568 ng/mL | Geometric Coefficient of Variation 30.37 |
| Cohort 2 (Tesofensine 0.50mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Day 14 | 7.827 ng/mL | Geometric Coefficient of Variation 35.67 |
| Cohort 2 (Tesofensine 0.50mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Metoprolol 100 mg | 7.306 ng/mL | Geometric Coefficient of Variation 29.61 |
| Cohort 2 (Tesofensine 0.50mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Day 13 | 8.056 ng/mL | Geometric Coefficient of Variation 35.33 |
| Cohort 3 (Tesofensine 0.75mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Metoprolol 100 mg | 12.21 ng/mL | Geometric Coefficient of Variation 23.99 |
| Cohort 3 (Tesofensine 0.75mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Day 23; | 13.96 ng/mL | Geometric Coefficient of Variation 28.6 |
| Cohort 3 (Tesofensine 0.75mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Day 13 | 12.20 ng/mL | Geometric Coefficient of Variation 21.29 |
| Cohort 3 (Tesofensine 0.75mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Metoprolol 25 mg | 11.96 ng/mL | Geometric Coefficient of Variation 24.09 |
| Cohort 3 (Tesofensine 0.75mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Metoprolol 50 mg | 11.52 ng/mL | Geometric Coefficient of Variation 23.62 |
| Cohort 3 (Tesofensine 0.75mg) | Trough Concentration (Ctrough) of Tesofensine on Day 13, Day 14, Day 15, Day 18, Day 21 and Day 23 | Day 14 | 12.10 ng/mL | Geometric Coefficient of Variation 18.4 |
Secondary
Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50
Any medicinal product, prescribed or over-the-counter (OTC), including herbal and other non-traditional remedies, was considered a concomitant medication.
Time frame: 30 days prior to Screening until the Safety Follow-up phone call, up to Day 50
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | BEPANTHEN/concomitant | 2 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METOPROLOL TARTRATE/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METOCLOPRAMIDE/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | ANAESTHETICS, LOCAL/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PANTOPRAZOLE/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | IBUPROFEN/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | ACETYLSALICYLIC ACID/concomitant | 1 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | UNACID [AMPICILLIN SODIUM;SULBACTAM SODIUM]/conco. | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | RISPERIDON BETA/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PARACETAMOL/concomitant | 1 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | IBUPROFEN/prior | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | LORAZEPAM/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | HALOPERIDOL/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | FOLIC ACID/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PARACETAMOL/prior | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PREDNISOLONE/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METEX [METHOTREXATE SODIUM]/concomitant | 0 Count of participants |
| Cohort 1 (Tesofensine 0.25mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METOPROLOL SUCCINATE/concomitant | 0 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METEX [METHOTREXATE SODIUM]/concomitant | 1 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METOPROLOL SUCCINATE/concomitant | 1 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | HALOPERIDOL/concomitant | 0 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | ANAESTHETICS, LOCAL/concomitant | 1 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | LORAZEPAM/concomitant | 0 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PREDNISOLONE/concomitant | 1 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METOCLOPRAMIDE/concomitant | 0 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | RISPERIDON BETA/concomitant | 0 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | IBUPROFEN/concomitant | 2 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PARACETAMOL/prior | 0 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METOPROLOL TARTRATE/concomitant | 1 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | BEPANTHEN/concomitant | 0 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PANTOPRAZOLE/concomitant | 1 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | UNACID [AMPICILLIN SODIUM;SULBACTAM SODIUM]/conco. | 1 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | IBUPROFEN/prior | 1 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PARACETAMOL/concomitant | 2 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | FOLIC ACID/concomitant | 1 Count of participants |
| Cohort 2 (Tesofensine 0.50mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | ACETYLSALICYLIC ACID/concomitant | 1 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | FOLIC ACID/concomitant | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PREDNISOLONE/concomitant | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PARACETAMOL/prior | 1 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | ACETYLSALICYLIC ACID/concomitant | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | BEPANTHEN/concomitant | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PARACETAMOL/concomitant | 1 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | ANAESTHETICS, LOCAL/concomitant | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | IBUPROFEN/concomitant | 1 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METOPROLOL TARTRATE/concomitant | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | PANTOPRAZOLE/concomitant | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | UNACID [AMPICILLIN SODIUM;SULBACTAM SODIUM]/conco. | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | IBUPROFEN/prior | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METEX [METHOTREXATE SODIUM]/concomitant | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METOPROLOL SUCCINATE/concomitant | 0 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | HALOPERIDOL/concomitant | 1 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | LORAZEPAM/concomitant | 1 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | METOCLOPRAMIDE/concomitant | 1 Count of participants |
| Cohort 3 (Tesofensine 0.75mg) | Use of Concomitant Medication From 30 Days Prior to Screening Until Day 50 | RISPERIDON BETA/concomitant | 1 Count of participants |