Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers (NCT NCT01348165)
NCT ID: NCT01348165
Last Updated: 2016-09-16
Results Overview
Number of subjects with drug related adverse events (AEs)
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
From baseline up to 28 days
Results posted on
2016-09-16
Participant Flow
Participant milestones
| Measure |
Placebo
A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
|
0.01 mg
BI 137882 with 0.01 mg Dose level
|
0.03 mg
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
6
|
6
|
6
|
1
|
6
|
|
Overall Study
COMPLETED
|
10
|
5
|
6
|
6
|
6
|
1
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
|
0.01 mg
BI 137882 with 0.01 mg Dose level
|
0.03 mg
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=1 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
n=6 Participants
BI 137882 with 0.6 mg Dose level
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.7 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
34.8 Years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
40.8 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
37.2 Years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
36.5 Years
STANDARD_DEVIATION 10.0 • n=21 Participants
|
42.0 Years
STANDARD_DEVIATION NA • n=8 Participants
|
35.5 Years
STANDARD_DEVIATION 8.5 • n=8 Participants
|
36.8 Years
STANDARD_DEVIATION 7.9 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
40 Participants
n=24 Participants
|
|
Smoking Status
Never Smoked
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=8 Participants
|
4 participants
n=8 Participants
|
22 participants
n=24 Participants
|
|
Smoking Status
Ex-Smoker
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
8 participants
n=24 Participants
|
|
Smoking Status
Currently Smokes
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
10 participants
n=24 Participants
|
|
Alcohol Status
Never Drinker
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
2 participants
n=24 Participants
|
|
Alcohol Status
Drinks - no interference
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
1 participants
n=8 Participants
|
5 participants
n=8 Participants
|
38 participants
n=24 Participants
|
|
Alcohol Status
Drinks - possible interference
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 28 daysPopulation: Treated Set which included all subjects who received one dose of trial medication
Number of subjects with drug related adverse events (AEs)
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=1 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
n=6 Participants
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Drug Related Adverse Events
|
6 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and 28 daysPopulation: Treated Set
Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=1 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
n=5 Participants
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Blood Pressure
SBP
|
1.0 mmHg
Standard Deviation 9.4
|
1.0 mmHg
Standard Deviation 3.4
|
2.8 mmHg
Standard Deviation 4.3
|
-3.3 mmHg
Standard Deviation 6.9
|
-5.8 mmHg
Standard Deviation 9.6
|
-16 mmHg
Standard Deviation NA
Measure of dispersion not applicable as only one patient in this treatment group
|
1.4 mmHg
Standard Deviation 7.0
|
|
Blood Pressure
DBP
|
-1.1 mmHg
Standard Deviation 3.7
|
-1.6 mmHg
Standard Deviation 6.8
|
-1.2 mmHg
Standard Deviation 2.7
|
-2.2 mmHg
Standard Deviation 4.2
|
-3.0 mmHg
Standard Deviation 3.7
|
-12.0 mmHg
Standard Deviation NA
Measure of dispersion not applicable as only one patient in this treatment group
|
0.8 mmHg
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: Baseline and 28 daysPopulation: Treated Set
Change from Baseline to 28 Days in Pulse Rate
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=1 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
n=5 Participants
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Pulse Rate (PR)
|
0.5 bpm
Standard Deviation 12.8
|
6.4 bpm
Standard Deviation 6.3
|
6.0 bpm
Standard Deviation 5.8
|
-0.7 bpm
Standard Deviation 6.2
|
0.7 bpm
Standard Deviation 5.2
|
3.0 bpm
Standard Deviation NA
Measure of dispersion not applicable as only one patient in this treatment group
|
0.8 bpm
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Baseline and 28 daysPopulation: Treated Set
Change from Baseline to 28 Days in Respiratory rate (RR)
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=1 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
n=5 Participants
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Respiratory Rate (RR)
|
0.3 breaths/min
Standard Deviation 4.6
|
1.2 breaths/min
Standard Deviation 5.4
|
1.3 breaths/min
Standard Deviation 1.6
|
0.5 breaths/min
Standard Deviation 2.1
|
-1.8 breaths/min
Standard Deviation 2.4
|
3.0 breaths/min
Standard Deviation NA
Measure of dispersion not applicable as only one patient in this treatment group
|
2.0 breaths/min
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Baseline and 28 daysPopulation: Treated Set
Change from baseline to 28 Days in Body temperature
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=1 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
n=5 Participants
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Body Temperature
|
0.0 degrees celcius
Standard Deviation 0.4
|
0.6 degrees celcius
Standard Deviation 0.4
|
-0.3 degrees celcius
Standard Deviation 0.3
|
0.1 degrees celcius
Standard Deviation 0.5
|
-0.3 degrees celcius
Standard Deviation 0.4
|
-0.1 degrees celcius
Standard Deviation NA
Measure of dispersion not applicable as only one patient in this treatment group
|
0.2 degrees celcius
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Treated Set
The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=1 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
n=5 Participants
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Assessment of Tolerability by Investigator
Good
|
10 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
|
Assessment of Tolerability by Investigator
Satisfactory
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of Tolerability by Investigator
Not satisfactory
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of Tolerability by Investigator
Bad
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of Tolerability by Investigator
Not assessable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.
Maximum measured concentration of BI 137882 in plasma.
Outcome measures
| Measure |
Placebo
n=6 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=6 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration (Cmax)
|
1.37 nmol/L
Geometric Coefficient of Variation 20.0
|
4.79 nmol/L
Geometric Coefficient of Variation 25.6
|
11.2 nmol/L
Geometric Coefficient of Variation 21.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.
Time from dosing to maximum measured concentration of the analyte in plasma.
Outcome measures
| Measure |
Placebo
n=6 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=6 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Measured Concentration (Tmax)
|
1.99 hours
Full Range 68.8 • Interval 0.98 to 4.0
|
1.48 hours
Full Range 62.9 • Interval 0.97 to 3.98
|
0.99 hours
Full Range 115 • Interval 0.48 to 5.98
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.
Area under the concentration-time curve of BI 137882 in plasma over the time interval from 0 extrapolated to infinity.
Outcome measures
| Measure |
Placebo
n=6 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=6 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Area Under the Curve 0 to Infinity (AUC0-infinity)
|
36.4 nmol*h/L
Geometric Coefficient of Variation 19.6
|
153 nmol*h/L
Geometric Coefficient of Variation 27.3
|
392 nmol*h/L
Geometric Coefficient of Variation 25.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.
Terminal half-life of BI 137882 in plasma.
Outcome measures
| Measure |
Placebo
n=6 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=6 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Terminal Half-life (t1/2)
|
22.8 hours
Geometric Coefficient of Variation 17.7
|
35.8 hours
Geometric Coefficient of Variation 46.8
|
37.2 hours
Geometric Coefficient of Variation 27.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point.
Outcome measures
| Measure |
Placebo
n=6 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=6 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
|
14.6 nmol*h/L
Geometric Coefficient of Variation 35.9
|
111 nmol*h/L
Geometric Coefficient of Variation 27.5
|
348 nmol*h/L
Geometric Coefficient of Variation 24.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.
Terminal rate constant in plasma.
Outcome measures
| Measure |
Placebo
n=6 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=6 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Terminal Rate Constant (λz)
|
0.0304 1/h
Geometric Coefficient of Variation 17.7
|
0.0194 1/h
Geometric Coefficient of Variation 46.8
|
0.0186 1/h
Geometric Coefficient of Variation 27.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.
Mean residence time of the analyte in the body after oral administration.
Outcome measures
| Measure |
Placebo
n=6 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=6 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Mean Residence Time (MRTpo)
|
32.9 hours
Geometric Coefficient of Variation 16.5
|
49.6 hours
Geometric Coefficient of Variation 41.1
|
52.8 hours
Geometric Coefficient of Variation 26.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.
Apparent clearance of the analyte in plasma after extravascular administration.
Outcome measures
| Measure |
Placebo
n=6 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=6 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F)
|
98.8 mL/min
Geometric Coefficient of Variation 19.6
|
58.7 mL/min
Geometric Coefficient of Variation 27.3
|
55.1 mL/min
Geometric Coefficient of Variation 25.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 administrationPopulation: Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.
Apparent volume of distribution of the analyte during the terminal phase.
Outcome measures
| Measure |
Placebo
n=6 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=6 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
BI 137882 with 0.1 mg Dose level
|
0.25 mg
BI 137882 with 0.25 mg Dose level
|
0.5 mg
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
195 L
Geometric Coefficient of Variation 11.5
|
182 L
Geometric Coefficient of Variation 28.2
|
177 L
Geometric Coefficient of Variation 9.34
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-4, 4-8, 8-12, and 12-24 hours after drug administrationPopulation: There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.
Amount of BI 137882 eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0-4, 4-8, 8-12, and 12-24 hours after drug administrationPopulation: There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.
Fraction of BI 137882 eliminated in urine from time point t1 to time point t2 (fet1-t2)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0-4, 4-8, 8-12, and 12-24 hours after drug administrationPopulation: There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.
Renal clearance of BI 137882 from the time point t1 until the time point t2 (CLR,t1-t2)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administrationPopulation: Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=6 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo
2 hours
|
-26.3 percentage of TNF-α production
Standard Deviation 45.0
|
-23.1 percentage of TNF-α production
Standard Deviation 35.6
|
-59.1 percentage of TNF-α production
Standard Deviation 35.9
|
-23.9 percentage of TNF-α production
Standard Deviation 24.0
|
1.13 percentage of TNF-α production
Standard Deviation 20.0
|
-0.41 percentage of TNF-α production
Standard Deviation 28.3
|
—
|
|
Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo
6 hours
|
1.13 percentage of TNF-α production
Standard Deviation 64.5
|
37.9 percentage of TNF-α production
Standard Deviation 19.5
|
-5.29 percentage of TNF-α production
Standard Deviation 34.7
|
11.4 percentage of TNF-α production
Standard Deviation 25.3
|
-2.17 percentage of TNF-α production
Standard Deviation 60.5
|
12.8 percentage of TNF-α production
Standard Deviation 54.2
|
—
|
|
Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo
24 hours
|
-23.2 percentage of TNF-α production
Standard Deviation 41.8
|
-11.6 percentage of TNF-α production
Standard Deviation 30.3
|
2.05 percentage of TNF-α production
Standard Deviation 20.7
|
-16.4 percentage of TNF-α production
Standard Deviation 41.7
|
4.78 percentage of TNF-α production
Standard Deviation 36.5
|
-17.1 percentage of TNF-α production
Standard Deviation 64.6
|
—
|
|
Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo
48 hours
|
-13.8 percentage of TNF-α production
Standard Deviation 44.3
|
-3.90 percentage of TNF-α production
Standard Deviation 56.9
|
7.49 percentage of TNF-α production
Standard Deviation 33.0
|
-61.0 percentage of TNF-α production
Standard Deviation 122
|
-0.98 percentage of TNF-α production
Standard Deviation 22.6
|
3.52 percentage of TNF-α production
Standard Deviation 51.5
|
—
|
SECONDARY outcome
Timeframe: 0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administrationPopulation: Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=6 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.
6 hours
|
3.57 percentage of LTB4 production
Standard Deviation 44.7
|
5.26 percentage of LTB4 production
Standard Deviation 21.4
|
22.8 percentage of LTB4 production
Standard Deviation 29.5
|
5.92 percentage of LTB4 production
Standard Deviation 15.8
|
-8.73 percentage of LTB4 production
Standard Deviation 39.3
|
-69.1 percentage of LTB4 production
Standard Deviation 74.0
|
—
|
|
Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.
24 hours
|
-19.2 percentage of LTB4 production
Standard Deviation 58.1
|
-19.1 percentage of LTB4 production
Standard Deviation 20.2
|
-25.3 percentage of LTB4 production
Standard Deviation 27.8
|
-12.1 percentage of LTB4 production
Standard Deviation 35.0
|
-59.4 percentage of LTB4 production
Standard Deviation 66.4
|
-61.2 percentage of LTB4 production
Standard Deviation 49.7
|
—
|
|
Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.
48 hours
|
-48.3 percentage of LTB4 production
Standard Deviation 89.7
|
-38.1 percentage of LTB4 production
Standard Deviation 43.8
|
-31.7 percentage of LTB4 production
Standard Deviation 23.2
|
1.11 percentage of LTB4 production
Standard Deviation 20.1
|
-41.6 percentage of LTB4 production
Standard Deviation 54.3
|
-94.2 percentage of LTB4 production
Standard Deviation 44.9
|
—
|
|
Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.
2 hours
|
-28.6 percentage of LTB4 production
Standard Deviation 47.3
|
-0.83 percentage of LTB4 production
Standard Deviation 16.6
|
15.0 percentage of LTB4 production
Standard Deviation 29.8
|
11.1 percentage of LTB4 production
Standard Deviation 11.3
|
-29.6 percentage of LTB4 production
Standard Deviation 35.6
|
-74.4 percentage of LTB4 production
Standard Deviation 48.2
|
—
|
SECONDARY outcome
Timeframe: 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administrationPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=6 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Area Under the Effect Curve (AUEC)
LPS
|
25200 pg*h/mL
Geometric Coefficient of Variation 85.9
|
34900 pg*h/mL
Geometric Coefficient of Variation 221
|
10900 pg*h/mL
Geometric Coefficient of Variation 654
|
NA pg*h/mL
Geometric Coefficient of Variation NA
No descriptive statistics calculated
|
46900 pg*h/mL
Geometric Coefficient of Variation 492
|
28700 pg*h/mL
Geometric Coefficient of Variation 1050
|
—
|
|
Area Under the Effect Curve (AUEC)
fMLP
|
NA pg*h/mL
Geometric Coefficient of Variation NA
No descriptive statistics calculated
|
NA pg*h/mL
Geometric Coefficient of Variation NA
No descriptive statistics calculated
|
25700 pg*h/mL
Geometric Coefficient of Variation 6170
|
45100 pg*h/mL
Geometric Coefficient of Variation 218
|
NA pg*h/mL
Geometric Coefficient of Variation NA
No descriptive statistics calculated
|
NA pg*h/mL
Geometric Coefficient of Variation NA
No descriptive statistics calculated
|
—
|
SECONDARY outcome
Timeframe: 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administrationPopulation: Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=6 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Maximum Effect (Emax)
TNF-alpha induced by LPS
|
13400 pg/mL
Geometric Coefficient of Variation 42.9
|
12000 pg/mL
Geometric Coefficient of Variation 30.1
|
9990 pg/mL
Geometric Coefficient of Variation 43.3
|
18200 pg/mL
Geometric Coefficient of Variation 47.3
|
21500 pg/mL
Geometric Coefficient of Variation 39.5
|
13800 pg/mL
Geometric Coefficient of Variation 32.9
|
—
|
|
Maximum Effect (Emax)
LTB4 induced by fMLP
|
60400 pg/mL
Geometric Coefficient of Variation 81.2
|
49400 pg/mL
Geometric Coefficient of Variation 28.5
|
51300 pg/mL
Geometric Coefficient of Variation 17.3
|
27800 pg/mL
Geometric Coefficient of Variation 64.4
|
44800 pg/mL
Geometric Coefficient of Variation 37.1
|
42100 pg/mL
Geometric Coefficient of Variation 46.3
|
—
|
SECONDARY outcome
Timeframe: 30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administrationPopulation: Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
A solution of 0.7% SDS and volume depends on corresponding dose group
|
0.01 mg
n=5 Participants
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 Participants
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 Participants
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 Participants
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=6 Participants
BI 137882 with 0.5 mg Dose level
|
0.6 mg
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Minimum Effect (Emin)
TNF-alpha induced by LPS
|
5200 pg/mL
Geometric Coefficient of Variation 50.7
|
5500 pg/mL
Geometric Coefficient of Variation 25.5
|
4730 pg/mL
Geometric Coefficient of Variation 57.7
|
8210 pg/mL
Geometric Coefficient of Variation 43.5
|
9570 pg/mL
Geometric Coefficient of Variation 63.5
|
5890 pg/mL
Geometric Coefficient of Variation 63.6
|
—
|
|
Minimum Effect (Emin)
LTB4 induced by fMLP
|
29000 pg/mL
Geometric Coefficient of Variation 67.8
|
31100 pg/mL
Geometric Coefficient of Variation 42.9
|
24000 pg/mL
Geometric Coefficient of Variation 32.4
|
19000 pg/mL
Geometric Coefficient of Variation 52.7
|
19500 pg/mL
Geometric Coefficient of Variation 31.4
|
19900 pg/mL
Geometric Coefficient of Variation 56.5
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
0.01 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.03 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.1 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.25 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.6 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=10 participants at risk
A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
|
0.01 mg
n=5 participants at risk
BI 137882 with 0.01 mg Dose level
|
0.03 mg
n=6 participants at risk
BI 137882 with 0.03 mg Dose level
|
0.1 mg
n=6 participants at risk
BI 137882 with 0.1 mg Dose level
|
0.25 mg
n=6 participants at risk
BI 137882 with 0.25 mg Dose level
|
0.5 mg
n=1 participants at risk
BI 137882 with 0.5 mg Dose level
|
0.6 mg
n=6 participants at risk
BI 137882 with 0.6 mg Dose level
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Rhinitis
|
10.0%
1/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
16.7%
1/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
16.7%
1/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
16.7%
1/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
20.0%
1/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
50.0%
3/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
33.3%
2/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
33.3%
2/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
16.7%
1/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
16.7%
1/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
40.0%
4/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
66.7%
4/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
83.3%
5/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
83.3%
5/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
16.7%
1/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
100.0%
1/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
33.3%
2/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
16.7%
1/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
20.0%
1/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
20.0%
1/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Injury, poisoning and procedural complications
Overdose
|
10.0%
1/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
100.0%
1/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/10 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/5 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
16.7%
1/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/1 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
0.00%
0/6 • Until 5 days after drug administration
Treatment emergent adverse events are presented, this excludes screening period and post treatment period.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place