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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023462-52 | EudraCT Number | EudraCT |
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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers
As a transition from preclinical investigations to clinical development in this first-in-man trial, safety, tolerability, and pharmacokinetics of BI 137882 will be assessed in healthy male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 137882 in the indication of COPD.
Healthy male subjects aged 21 - 50 years will be recruited for this study. They provide a relatively stable physiological, biochemical and hormonal basis (steady state) for studying drug effects, they show no disease-related variation and they are not taking concomitant medication.
Within each dose group, all actively treated individuals will receive the same BI 137882 dose. The next higher dose will only be administered if the treatment in the preceding dose group was safe and well tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 137882 Dose 1 | Experimental | Powder for oral solution |
|
| BI 137882 Dose 2 | Experimental | Powder for oral solution |
|
| BI 137882 Dose 3 | Experimental | Powder for oral solution |
|
| BI 137882 Dose 4 | Experimental | Powder for oral solution |
|
| BI 137882 Dose 5 | Experimental | Powder for oral solution |
|
| BI 137882 Dose 6 | Experimental | Powder for oral solution |
|
| BI 137882 Dose 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 137882 | Drug | Powder for oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drug Related Adverse Events | Number of subjects with drug related adverse events (AEs) | From baseline up to 28 days |
| Blood Pressure | Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP) | Baseline and 28 days |
| Pulse Rate (PR) | Change from Baseline to 28 Days in Pulse Rate | Baseline and 28 days |
| Respiratory Rate (RR) | Change from Baseline to 28 Days in Respiratory rate (RR) | Baseline and 28 days |
| Body Temperature | Change from baseline to 28 Days in Body temperature | Baseline and 28 days |
| Assessment of Tolerability by Investigator | The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration (Cmax) | Maximum measured concentration of BI 137882 in plasma. | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
| Time to Maximum Measured Concentration (Tmax) |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group |
| FG001 | 0.01 mg | BI 137882 with 0.01 mg Dose level |
| FG002 | 0.03 mg | BI 137882 with 0.03 mg Dose level |
| FG003 | 0.1 mg | BI 137882 with 0.1 mg Dose level |
| FG004 | 0.25 mg | BI 137882 with 0.25 mg Dose level |
| FG005 | 0.5 mg | BI 137882 with 0.5 mg Dose level |
| FG006 | 0.6 mg | BI 137882 with 0.6 mg Dose level |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set which included all subjects who received one dose of trial medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A solution of 0.7% SDS and volume depends on corresponding dose group |
| BG001 | 0.01 mg | BI 137882 with 0.01 mg Dose level |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Drug Related Adverse Events | Number of subjects with drug related adverse events (AEs) | Treated Set which included all subjects who received one dose of trial medication | Posted | Number | Participants | From baseline up to 28 days |
|
Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
The trial was put on hold due to a serious adverse event (post-treatment period) which was evaluated to be not drug related and the trial was subsequently terminated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Experimental |
Powder for oral solution |
|
| BI 137882 Dose 8 | Experimental | Powder for oral solution |
|
| BI 137882 Dose 9 | Experimental | Powder for oral solution |
|
| Placebo | Placebo Comparator | Powder for oral solution |
|
| Placebo | Drug | Powder for oral solution |
|
Time from dosing to maximum measured concentration of the analyte in plasma. |
| 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
| Area Under the Curve 0 to Infinity (AUC0-infinity) | Area under the concentration-time curve of BI 137882 in plasma over the time interval from 0 extrapolated to infinity. | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
| Terminal Half-life (t1/2) | Terminal half-life of BI 137882 in plasma. | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
| Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point. | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
| Terminal Rate Constant (λz) | Terminal rate constant in plasma. | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
| Mean Residence Time (MRTpo) | Mean residence time of the analyte in the body after oral administration. | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
| Apparent Clearance (CL/F) | Apparent clearance of the analyte in plasma after extravascular administration. | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
| Apparent Volume of Distribution (Vz/F) | Apparent volume of distribution of the analyte during the terminal phase. | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
| Amount of BI 137882 Eliminated in Urine From the Time Point t1 to Time Point t2 | Amount of BI 137882 eliminated in urine from the time point t1 to time point t2 (Aet1-t2) | 0-4, 4-8, 8-12, and 12-24 hours after drug administration |
| Fraction of BI 137882 Eliminated in Urine From Time Point t1 to Time Point t2 | Fraction of BI 137882 eliminated in urine from time point t1 to time point t2 (fet1-t2) | 0-4, 4-8, 8-12, and 12-24 hours after drug administration |
| Renal Clearance of BI 137882 From the Time Point t1 Until the Time Point t2 | Renal clearance of BI 137882 from the time point t1 until the time point t2 (CLR,t1-t2) | 0-4, 4-8, 8-12, and 12-24 hours after drug administration |
| Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo | Concentrations of TNF-α in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Concentrations of TNF-α in blood drawn after treatment with BI 137882 were compared with those in pre-dose samples to calculate the percent of inhibition of LPS induction of TNF-α production. Results indicate percent change from baseline of LPS-induced TNF-α production. A positive value indicates inhibition of the production. | 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration |
| Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo. | Percent of inhibition of fMLP induction of LTB4 production. Concentrations of LTB4 in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Results indicate percent change from baseline of fMLP induction of LTB4 production. A positive value indicates inhibition of the production. | 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration |
| Area Under the Effect Curve (AUEC) | Area under the effect curve for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production. | 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration |
| Maximum Effect (Emax) | Maximum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production. | 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration |
| Minimum Effect (Emin) | Minimum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production. | 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration |
| BG002 | 0.03 mg | BI 137882 with 0.03 mg Dose level |
| BG003 | 0.1 mg | BI 137882 with 0.1 mg Dose level |
| BG004 | 0.25 mg | BI 137882 with 0.25 mg Dose level |
| BG005 | 0.5 mg | BI 137882 with 0.5 mg Dose level |
| BG006 | 0.6 mg | BI 137882 with 0.6 mg Dose level |
| BG007 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Smoking Status | Number | participants |
|
| Alcohol Status | Level of interference was based on if a subject drank alcohol to an extent that would interfere with the objectives of the trial. | Number | participants |
|
BI 137882 with 0.03 mg Dose level
| OG003 | 0.1 mg | BI 137882 with 0.1 mg Dose level |
| OG004 | 0.25 mg | BI 137882 with 0.25 mg Dose level |
| OG005 | 0.5 mg | BI 137882 with 0.5 mg Dose level |
| OG006 | 0.6 mg | BI 137882 with 0.6 mg Dose level |
|
|
| Primary | Blood Pressure | Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP) | Treated Set | Posted | Mean | Standard Deviation | mmHg | Baseline and 28 days |
|
|
|
| Primary | Pulse Rate (PR) | Change from Baseline to 28 Days in Pulse Rate | Treated Set | Posted | Mean | Standard Deviation | bpm | Baseline and 28 days |
|
|
|
| Primary | Respiratory Rate (RR) | Change from Baseline to 28 Days in Respiratory rate (RR) | Treated Set | Posted | Mean | Standard Deviation | breaths/min | Baseline and 28 days |
|
|
|
| Secondary | Maximum Measured Concentration (Cmax) | Maximum measured concentration of BI 137882 in plasma. | Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
|
|
|
| Secondary | Time to Maximum Measured Concentration (Tmax) | Time from dosing to maximum measured concentration of the analyte in plasma. | Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated. | Posted | Median | Full Range | hours | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
|
|
|
| Secondary | Area Under the Curve 0 to Infinity (AUC0-infinity) | Area under the concentration-time curve of BI 137882 in plasma over the time interval from 0 extrapolated to infinity. | Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
|
|
|
| Secondary | Terminal Half-life (t1/2) | Terminal half-life of BI 137882 in plasma. | Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
|
|
|
| Secondary | Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point. | Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
|
|
|
| Secondary | Terminal Rate Constant (λz) | Terminal rate constant in plasma. | Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
|
|
|
| Secondary | Mean Residence Time (MRTpo) | Mean residence time of the analyte in the body after oral administration. | Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
|
|
|
| Secondary | Apparent Clearance (CL/F) | Apparent clearance of the analyte in plasma after extravascular administration. | Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) | Apparent volume of distribution of the analyte during the terminal phase. | Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration |
|
|
|
| Secondary | Amount of BI 137882 Eliminated in Urine From the Time Point t1 to Time Point t2 | Amount of BI 137882 eliminated in urine from the time point t1 to time point t2 (Aet1-t2) | There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated. | Posted | 0-4, 4-8, 8-12, and 12-24 hours after drug administration |
|
|
| Secondary | Fraction of BI 137882 Eliminated in Urine From Time Point t1 to Time Point t2 | Fraction of BI 137882 eliminated in urine from time point t1 to time point t2 (fet1-t2) | There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated. | Posted | 0-4, 4-8, 8-12, and 12-24 hours after drug administration |
|
|
| Secondary | Renal Clearance of BI 137882 From the Time Point t1 Until the Time Point t2 | Renal clearance of BI 137882 from the time point t1 until the time point t2 (CLR,t1-t2) | There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated. | Posted | 0-4, 4-8, 8-12, and 12-24 hours after drug administration |
|
|
| Secondary | Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo | Concentrations of TNF-α in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Concentrations of TNF-α in blood drawn after treatment with BI 137882 were compared with those in pre-dose samples to calculate the percent of inhibition of LPS induction of TNF-α production. Results indicate percent change from baseline of LPS-induced TNF-α production. A positive value indicates inhibition of the production. | Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group. | Posted | Mean | Standard Deviation | percentage of TNF-α production | 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration |
|
|
|
| Secondary | Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo. | Percent of inhibition of fMLP induction of LTB4 production. Concentrations of LTB4 in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Results indicate percent change from baseline of fMLP induction of LTB4 production. A positive value indicates inhibition of the production. | Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group. | Posted | Mean | Standard Deviation | percentage of LTB4 production | 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration |
|
|
|
| Secondary | Area Under the Effect Curve (AUEC) | Area under the effect curve for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production. | Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group. Geometric mean and geometric coefficient of variation was not calculated for any parameter in any dose group in which zero or a negative value was calculated, as geometric means cannot be calculated with negative or zero values. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration |
|
|
|
| Secondary | Maximum Effect (Emax) | Maximum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production. | Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration |
|
|
|
| Secondary | Minimum Effect (Emin) | Minimum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production. | Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration |
|
|
|
| Primary | Body Temperature | Change from baseline to 28 Days in Body temperature | Treated Set | Posted | Mean | Standard Deviation | degrees celcius | Baseline and 28 days |
|
|
|
| Primary | Assessment of Tolerability by Investigator | The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. | Treated Set | Posted | Number | Participants | 28 days |
|
|
|
| 0 |
| 10 |
| 7 |
| 10 |
| EG001 | 0.01 mg | BI 137882 with 0.01 mg Dose level | 0 | 5 | 1 | 5 |
| EG002 | 0.03 mg | BI 137882 with 0.03 mg Dose level | 0 | 6 | 5 | 6 |
| EG003 | 0.1 mg | BI 137882 with 0.1 mg Dose level | 0 | 6 | 5 | 6 |
| EG004 | 0.25 mg | BI 137882 with 0.25 mg Dose level | 0 | 6 | 5 | 6 |
| EG005 | 0.5 mg | BI 137882 with 0.5 mg Dose level | 0 | 1 | 1 | 1 |
| EG006 | 0.6 mg | BI 137882 with 0.6 mg Dose level | 0 | 6 | 1 | 6 |
| Hypervigilance | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MEDDRA 14.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| DBP |
|
| 6 hours |
|
| 24 hours |
|
| 48 hours |
|
| 6 hours |
|
| 24 hours |
|
| 48 hours |
|
| fMLP |
|
| LTB4 induced by fMLP |
|
| LTB4 induced by fMLP |
|
| Satisfactory |
|
| Not satisfactory |
|
| Bad |
|
| Not assessable |
|