Anxiety Disorders
Conditions
Keywords
Dose escalation, QTc Interval, Paroxetine, Healthy Adults
Brief summary
The primary purpose of the study is to evaluate the potential effect of paroxetine on QTc interval following escalating doses in healthy participants. Participants with no history of cardiac abnormalities or mood disorders will be enrolled. During the study, participants will take paroxetine at three incremental dose levels. Participants will attend the clinic at screening, baseline, at the end of each dose level administration week, and a final study exit visit. While on treatment outside of clinic visits, participants will be followed-up via video-call. A concentration-QTc analysis will assess any potential correlation between paroxetine plasma concentration and QTc prolongation. In addition, the occurrence of any side-effects will be compared between on and off treatment.
Interventions
DRUGParoxetine
Paroxetine will be administered
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants, both male and female, aged between 18 to 65 years, at the time of signing the informed consent. * Participants determined as healthy based on medical evaluation by an experienced physician. * A female participant is eligible to participate if she is of: * Nonchildbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. * Child-bearing potential and agrees to use one of the contraception methods for an appropriate time as mentioned in the study protocol. * Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase, and bilirubin ≤ 1.5x (Upper Limit of Normal) ULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Body weight ≥ 45 kilogram (kg) and Body Mass Index (BMI) within the range 18 to 29.5 kilogram per metre square (kg/m2) (inclusive). * No significant abnormality on 12-lead Electrocardiogram (ECG) at Screening in supine position, including the following specific requirements: 1. Heart rate ≥ 40 beats per minute 2. PR interval ≤ 220 milliseconds (msec) (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used) 3. Q waves \< 50 msec (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used) 4. QRS interval to be ≥ 60msec and \< 120msec (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used) 5. The waveforms must enable the QT interval to be clearly defined 6. QTcF interval must be \< 450msec (machine or manual reading). * A signed and dated written informed consent obtained from participants capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Non-smokers (never smoked or not smoking for \>6 months with \<10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked) or light smokers (less than 5 cigarettes per day).
Exclusion criteria
* History or presence of any medically significant disease that may cause additional risk or interfere with the study procedures or outcome. * History of symptomatic arrhythmias. * History of hypersensitivity to paroxetine and excipients * History of abnormal coagulation parameters, bleeding disorders or conditions which may predispose to bleeding. * History of, or active suicidal ideation. Includes assessment using the Columbia Suicide Severity Rating Scale (C-SSRS) * Must not have a pre-diagnosed mood disorder * Participant is mentally or legally incapacitated. * A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHG) at Screening. * A supine heart rate outside the range 50-90 beats per minute (bpm) at Screening. * A positive screening Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones). * A positive drug/alcohol screen at screening or prior to dosing. * A positive test for Human Immune Virus (HIV) antibody at Screening. * History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 millilitre \[ml\]) of beer, 1 glass (125ml) of wine or 1 (25 ml) measure of spirits. * The participant has participated in a clinical trial and has received an investigational product within the following time prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * Exposure to more than four new chemical entities within 12 months prior to the first dosing day. * Use of the following medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of the study medication: monoamine oxidase inhibitors (including linezolid), thioridazine, pimozide, serotonergic drugs (including L-tryptophan, triptans, tramadol, selective serotonin reuptake inhibitors, lithium and fentanyl, tamoxifen, anti-coagulants, clozapine, phenothiazines, tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs, Cox-2 inhibitors, antiarrhythmics, quinolone antibiotics, macrolides (including clarithromycin and erythromycin), ketoconazole and itraconazole * Use of non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication. * No current use of any medication other than paracetamol (doses ≤2 grams/day). * Consumption of Seville oranges, pummelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication. * Where participation in the study would result in donation of blood or blood products more than 500 mL within a 3-month period. * Pregnant females as determined by positive serum β-HCG test at screening or serum/ urine beta-Human chorionic gonadotropin (HCG) prior to dosing. * Lactating females. * Unwillingness or inability to follow the procedures outlined in the protocol. * Participants with unsuitable veins for cannulation and repeat venepuncture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1 | A standard 12-lead electrocardiogram (ECG) were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day -1) and Day 48 | SBP and DBP were measured in the supine position using a semi-automatic blood pressure recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and standard deviation (SD) values of vital sign assessments at Day 48 are reported. |
| Change From Baseline in Vital Sign: Pulse Rate | Baseline (Day -1) and Day 48 | Pulse rate was measured in the supine position using a semi-automatic recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported. |
| Change From Baseline in Vital Sign: Body Temperature | Baseline (Day -1) and Day 48 | Body temperature measurements were performed in participants. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 48 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or any other situation as determined per medical and scientific judgment. |
| Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Up to Day 48 | The laboratory measurements included hematology, clinical chemistry and coagulation parameters. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets, Reticulocytes, Alanine Aminotransferase, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Potassium, Sodium, Creatinine kinase, Prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalized ration (INR). Clinical significance was determined by the investigator. Number of participants with clinically significant findings in hematology, clinical chemistry and coagulation were reported. |
| Number of Participants With Clinically Significant Findings for Vital Signs | Up to Day 48 | Vital signs included systolic and diastolic blood pressure, pulse rate and body temperature. Blood pressure and pulse rate were measured with the participant in supine position after at least 5 minutes rest. Clinical significance was determined by the investigator. Number of participants with clinically significant findings in vital signs were reported. |
| Number of Participants With Clinically Significant Findings for Physical Examinations | Up to Day 48 | Physical examinations included assessment of skin, lungs, cardiovascular system, and abdomen (liver and spleen). Clinical significance was determined by the investigator. Number of Participants with clinically significant findings for physical examinations were reported. |
Countries
United Kingdom
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Participant flow
Recruitment details
This study investigated the cardiac effects, safety, and tolerability of paroxetine in healthy adult participants.
Pre-assignment details
A total of 38 participants were enrolled in the study to receive 20 milligrams (mg), 40 mg and 60 mg doses of paroxetine.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Receiving Paroxetine Participants received paroxetine tablets titrated to a dose of 60 mg once daily at increments of 20 mg per week. Participants received paroxetine 20 mg tablets, orally once daily from Days 1 to 7 followed by paroxetine 40 mg tablets, orally once daily from Days 8 to 14 and then paroxetine 60 mg tablets orally once daily from Days 15 to 21. Participants were followed-up for up-to Day 48. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | All Study Participants Receiving Paroxetine |
|---|---|
| Age, Continuous | 37.3 Years STANDARD_DEVIATION 11.48 |
| Race/Ethnicity, Customized De-identified | 13 Participants |
| Race/Ethnicity, Customized White | 25 Participants |
| Sex/Gender, Customized Female | 15 Participants |
| Sex/Gender, Customized Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 33 | 0 / 32 |
| other Total, other adverse events | 23 / 38 | 19 / 33 | 9 / 32 |
| serious Total, serious adverse events | 1 / 38 | 0 / 33 | 0 / 32 |
Outcome results
Primary
Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
A standard 12-lead electrocardiogram (ECG) were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value.
Time frame: Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1
Population: Pharmacodynamic Population included all participants in the Safety Population who had at least 1 non-missing ECG assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 1 Hour Post-dose on Day 1 | 2.2 Milliseconds | Standard Deviation 10.68 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 4 Hours Post-dose on Day 1 | -4.4 Milliseconds | Standard Deviation 9.68 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 3 Hours Post-dose on Day 1 | -7.1 Milliseconds | Standard Deviation 8.48 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 10 Hours Post-dose on Day 1 | -5.0 Milliseconds | Standard Deviation 9.62 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 4.5 Hours Post-dose on Day 1 | -2.5 Milliseconds | Standard Deviation 8.26 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 0.25 Hours Pre-dose on Day 1 | 1.9 Milliseconds | Standard Deviation 7.37 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 12 Hours Post-dose on Day 1 | -0.5 Milliseconds | Standard Deviation 10.41 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 5 Hours Post-dose on Day 1 | -0.3 Milliseconds | Standard Deviation 10.08 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 8 Hours Post-dose on Day 1 | 1.6 Milliseconds | Standard Deviation 12.34 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 2 Hours Post-dose on Day 1 | -3.0 Milliseconds | Standard Deviation 9.54 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 5.5 Hours Post-dose on Day 1 | 4.0 Milliseconds | Standard Deviation 8.49 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 6 Hours Post-dose on Day 1 | 4.2 Milliseconds | Standard Deviation 9.15 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 5.5 Hours Post-dose on Day 1 | 3.6 Milliseconds | Standard Deviation 11.91 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 6 Hours Post-dose on Day 1 | 4.0 Milliseconds | Standard Deviation 11.35 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 8 Hours Post-dose on Day 1 | -0.2 Milliseconds | Standard Deviation 13.35 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 10 Hours Post-dose on Day 1 | -5.2 Milliseconds | Standard Deviation 10.22 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 12 Hours Post-dose on Day 1 | -4.0 Milliseconds | Standard Deviation 10.61 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 3 Hours Post-dose on Day 1 | -5.4 Milliseconds | Standard Deviation 10.1 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 4 Hours Post-dose on Day 1 | -4.2 Milliseconds | Standard Deviation 10.48 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 1 Hour Post-dose on Day 1 | 2.9 Milliseconds | Standard Deviation 12.6 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 4.5 Hours Post-dose on Day 1 | -1.2 Milliseconds | Standard Deviation 11.85 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 0.25 Hours Pre-dose on Day 1 | 1.0 Milliseconds | Standard Deviation 10.82 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 5 Hours Post-dose on Day 1 | 0.9 Milliseconds | Standard Deviation 12.53 |
| Participants Who Received Paroxetine 40 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 2 Hours Post-dose on Day 1 | -2.9 Milliseconds | Standard Deviation 10.83 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 12 Hours Post-dose on Day 1 | -4.2 Milliseconds | Standard Deviation 12.06 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 0.25 Hours Pre-dose on Day 1 | 0.9 Milliseconds | Standard Deviation 9.88 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 1 Hour Post-dose on Day 1 | 0.6 Milliseconds | Standard Deviation 13.35 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 2 Hours Post-dose on Day 1 | -4.2 Milliseconds | Standard Deviation 11.05 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 3 Hours Post-dose on Day 1 | -6.9 Milliseconds | Standard Deviation 8.92 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 4 Hours Post-dose on Day 1 | -4.6 Milliseconds | Standard Deviation 10.7 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 4.5 Hours Post-dose on Day 1 | -1.5 Milliseconds | Standard Deviation 11.15 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 5 Hours Post-dose on Day 1 | -0.7 Milliseconds | Standard Deviation 10.37 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 5.5 Hours Post-dose on Day 1 | 3.2 Milliseconds | Standard Deviation 10.57 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 6 Hours Post-dose on Day 1 | 4.7 Milliseconds | Standard Deviation 8.51 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 8 Hours Post-dose on Day 1 | -0.1 Milliseconds | Standard Deviation 11.76 |
| Participants Who Received Paroxetine 60 mg | Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval) | 10 Hours Post-dose on Day 1 | -5.0 Milliseconds | Standard Deviation 12.51 |
Secondary
Change From Baseline in Vital Sign: Body Temperature
Body temperature measurements were performed in participants. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.
Time frame: Baseline (Day -1) and Day 48
Population: Safety Population included all participants who received at least one dose of study intervention. As all participants received 20, 40 and 60 mg of paroxetine and as there was no intent of comparison of vital signs across these doses, the results were planned to be presented as a single overall arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Vital Sign: Body Temperature | 0.047 Degrees Celsius | Standard Deviation 0.1109 |
Secondary
Change From Baseline in Vital Sign: Pulse Rate
Pulse rate was measured in the supine position using a semi-automatic recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.
Time frame: Baseline (Day -1) and Day 48
Population: Safety Population included all participants who received at least one dose of study intervention. As all participants received 20, 40 and 60 mg of paroxetine and as there was no intent of comparison of vital signs across these doses, the results were planned to be presented as a single overall arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Vital Sign: Pulse Rate | 1.842 Beats per minute (bpm) | Standard Deviation 5.0325 |
Secondary
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in the supine position using a semi-automatic blood pressure recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and standard deviation (SD) values of vital sign assessments at Day 48 are reported.
Time frame: Baseline (Day -1) and Day 48
Population: Safety Population included all participants who received at least one dose of study intervention. As all participants received 20, 40 and 60 mg of paroxetine and as there was no intent of comparison of vital signs across these doses, the results were planned to be presented as a single overall arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Systolic Blood Pressure | 6.474 Millimeters of mercury (mmHg) | Standard Deviation 5.8713 |
| Participants Who Received Paroxetine 20 mg | Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Diastolic Blood Pressure | 4.763 Millimeters of mercury (mmHg) | Standard Deviation 5.934 |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or any other situation as determined per medical and scientific judgment.
Time frame: Up to Day 48
Population: Safety Population included all participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Who Received Paroxetine 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 23 Participants |
| Participants Who Received Paroxetine 20 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Participants Who Received Paroxetine 40 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 19 Participants |
| Participants Who Received Paroxetine 40 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Participants Who Received Paroxetine 60 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 9 Participants |
| Participants Who Received Paroxetine 60 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Secondary
Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters
The laboratory measurements included hematology, clinical chemistry and coagulation parameters. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets, Reticulocytes, Alanine Aminotransferase, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Potassium, Sodium, Creatinine kinase, Prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalized ration (INR). Clinical significance was determined by the investigator. Number of participants with clinically significant findings in hematology, clinical chemistry and coagulation were reported.
Time frame: Up to Day 48
Population: Safety Population included all participants who received at least one dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Who Received Paroxetine 20 mg | Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Clinical chemistry | 0 Participants |
| Participants Who Received Paroxetine 20 mg | Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Hematology | 0 Participants |
| Participants Who Received Paroxetine 20 mg | Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Coagulation | 0 Participants |
| Participants Who Received Paroxetine 40 mg | Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Clinical chemistry | 0 Participants |
| Participants Who Received Paroxetine 40 mg | Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Hematology | 0 Participants |
| Participants Who Received Paroxetine 40 mg | Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Coagulation | 0 Participants |
| Participants Who Received Paroxetine 60 mg | Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Hematology | 0 Participants |
| Participants Who Received Paroxetine 60 mg | Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Coagulation | 0 Participants |
| Participants Who Received Paroxetine 60 mg | Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters | Clinical chemistry | 0 Participants |
Secondary
Number of Participants With Clinically Significant Findings for Physical Examinations
Physical examinations included assessment of skin, lungs, cardiovascular system, and abdomen (liver and spleen). Clinical significance was determined by the investigator. Number of Participants with clinically significant findings for physical examinations were reported.
Time frame: Up to Day 48
Population: Safety Population included all participants who received at least one dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Received Paroxetine 20 mg | Number of Participants With Clinically Significant Findings for Physical Examinations | 0 Participants |
| Participants Who Received Paroxetine 40 mg | Number of Participants With Clinically Significant Findings for Physical Examinations | 0 Participants |
| Participants Who Received Paroxetine 60 mg | Number of Participants With Clinically Significant Findings for Physical Examinations | 0 Participants |
Secondary
Number of Participants With Clinically Significant Findings for Vital Signs
Vital signs included systolic and diastolic blood pressure, pulse rate and body temperature. Blood pressure and pulse rate were measured with the participant in supine position after at least 5 minutes rest. Clinical significance was determined by the investigator. Number of participants with clinically significant findings in vital signs were reported.
Time frame: Up to Day 48
Population: Safety Population included all participants who received at least one dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Received Paroxetine 20 mg | Number of Participants With Clinically Significant Findings for Vital Signs | 0 Participants |
| Participants Who Received Paroxetine 40 mg | Number of Participants With Clinically Significant Findings for Vital Signs | 0 Participants |
| Participants Who Received Paroxetine 60 mg | Number of Participants With Clinically Significant Findings for Vital Signs | 0 Participants |