Trial Outcomes & Findings for A Study in Healthy Men to Test How Different Doses of BI 1595043 Are Tolerated (NCT NCT04439838)
NCT ID: NCT04439838
Last Updated: 2024-02-21
Results Overview
Percentage of participants with drug-related adverse events (AEs) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
From drug administration until end of trial, up to 15 days.
Results posted on
2024-02-21
Participant Flow
A single-blind, partially randomised, placebo-controlled study to test how different doses of BI 1595043 are tolerated in healthy men.
Only subjects that met all the inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring was adhered throughout the trial conduct.
Participant milestones
| Measure |
Matching Placebo
Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
1 mg BI 1595043
Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
3 mg BI 1595043
Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
6 mg BI 1595043
Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
12 mg BI 1595043
Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
25 mg BI 1595043
Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
50 mg BI 1595043
Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
90 mg BI 1595043
Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
160 mg BI 1595043
Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
16
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Matching Placebo
Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
1 mg BI 1595043
Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
3 mg BI 1595043
Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
6 mg BI 1595043
Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
12 mg BI 1595043
Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
25 mg BI 1595043
Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
50 mg BI 1595043
Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
90 mg BI 1595043
Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
160 mg BI 1595043
Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study in Healthy Men to Test How Different Doses of BI 1595043 Are Tolerated
Baseline characteristics by cohort
| Measure |
Matching Placebo
n=16 Participants
Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
1 mg BI 1595043
n=6 Participants
Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
3 mg BI 1595043
n=6 Participants
Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
6 mg BI 1595043
n=6 Participants
Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
12 mg BI 1595043
n=6 Participants
Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
25 mg BI 1595043
n=6 Participants
Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
50 mg BI 1595043
n=6 Participants
Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
90 mg BI 1595043
n=6 Participants
Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
160 mg BI 1595043
n=6 Participants
Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
39.8 Years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
37.8 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
40.2 Years
STANDARD_DEVIATION 4.8 • n=4 Participants
|
35.3 Years
STANDARD_DEVIATION 9.1 • n=21 Participants
|
34.2 Years
STANDARD_DEVIATION 11.1 • n=10 Participants
|
29.0 Years
STANDARD_DEVIATION 4.0 • n=115 Participants
|
37.7 Years
STANDARD_DEVIATION 8.7 • n=6 Participants
|
34.2 Years
STANDARD_DEVIATION 10.0 • n=6 Participants
|
35.6 Years
STANDARD_DEVIATION 8.1 • n=64 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
64 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
62 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
59 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: From drug administration until end of trial, up to 15 days.Population: Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
Percentage of participants with drug-related adverse events (AEs) is reported.
Outcome measures
| Measure |
Matching Placebo
n=16 Participants
Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
1 mg BI 1595043
n=6 Participants
Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
3 mg BI 1595043
n=6 Participants
Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
6 mg BI 1595043
n=6 Participants
Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
12 mg BI 1595043
n=6 Participants
Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
25 mg BI 1595043
n=6 Participants
Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
50 mg BI 1595043
n=6 Participants
Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
90 mg BI 1595043
n=6 Participants
Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
160 mg BI 1595043
n=6 Participants
Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events (AEs)
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Within 3 hours prior to drug administration and 0.5, 1, 1.5, 2*, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 168 and 192 hours after drug administration. * Only for dose group "12 mg BI 1595043".Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with non-missing values are reported.
Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) is reported.
Outcome measures
| Measure |
Matching Placebo
n=6 Participants
Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
1 mg BI 1595043
n=6 Participants
Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
3 mg BI 1595043
n=6 Participants
Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
6 mg BI 1595043
n=6 Participants
Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
12 mg BI 1595043
n=6 Participants
Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
25 mg BI 1595043
n=6 Participants
Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
50 mg BI 1595043
n=6 Participants
Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
90 mg BI 1595043
n=5 Participants
Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
160 mg BI 1595043
Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
|
294 Hours * nanomole / Liter
Geometric Coefficient of Variation 26.9
|
571 Hours * nanomole / Liter
Geometric Coefficient of Variation 14.9
|
958 Hours * nanomole / Liter
Geometric Coefficient of Variation 19.9
|
1850 Hours * nanomole / Liter
Geometric Coefficient of Variation 19.6
|
3210 Hours * nanomole / Liter
Geometric Coefficient of Variation 19.7
|
5510 Hours * nanomole / Liter
Geometric Coefficient of Variation 20.3
|
12300 Hours * nanomole / Liter
Geometric Coefficient of Variation 11.8
|
18700 Hours * nanomole / Liter
Geometric Coefficient of Variation 10.1
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours prior to drug administration and 0.5, 1, 1.5, 2*, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 168 and 192 hours after drug administration. * Only for dose group "12 mg BI 1595043".Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment.
Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported.
Outcome measures
| Measure |
Matching Placebo
n=6 Participants
Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
1 mg BI 1595043
n=6 Participants
Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
3 mg BI 1595043
n=6 Participants
Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
6 mg BI 1595043
n=6 Participants
Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
12 mg BI 1595043
n=6 Participants
Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
25 mg BI 1595043
n=6 Participants
Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
50 mg BI 1595043
n=6 Participants
Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
90 mg BI 1595043
n=6 Participants
Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
160 mg BI 1595043
Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1595043 in Plasma (Cmax)
|
23.6 Nanomole / Liter
Geometric Coefficient of Variation 16.7
|
78.4 Nanomole / Liter
Geometric Coefficient of Variation 10.9
|
119 Nanomole / Liter
Geometric Coefficient of Variation 21.2
|
286 Nanomole / Liter
Geometric Coefficient of Variation 20.5
|
516 Nanomole / Liter
Geometric Coefficient of Variation 26.2
|
1100 Nanomole / Liter
Geometric Coefficient of Variation 27.1
|
2500 Nanomole / Liter
Geometric Coefficient of Variation 20.0
|
4620 Nanomole / Liter
Geometric Coefficient of Variation 21.8
|
—
|
Adverse Events
Matching Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1 mg BI 1595043
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 mg BI 1595043
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
6 mg BI 1595043
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
12 mg BI 1595043
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
25 mg BI 1595043
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 mg BI 1595043
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
90 mg BI 1595043
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
160 mg BI 1595043
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Matching Placebo
n=16 participants at risk
Matching placebo administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours.
|
1 mg BI 1595043
n=6 participants at risk
Participants were administered 0.4 ml oral solution of BI 1595043 concentrated 2.5 milligram (mg)/ milliliter (mL) (total dose: 1 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
3 mg BI 1595043
n=6 participants at risk
Participants were administered 1.2 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 3 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
6 mg BI 1595043
n=6 participants at risk
Participants were administered 2.4 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 6 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
12 mg BI 1595043
n=6 participants at risk
Participants were administered 4.8 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 12 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
25 mg BI 1595043
n=6 participants at risk
Participants were administered 10 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 25 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
50 mg BI 1595043
n=6 participants at risk
Participants were administered 20 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 50 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
90 mg BI 1595043
n=6 participants at risk
Participants were administered 36 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 90 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
160 mg BI 1595043
n=6 participants at risk
Participants were administered 64 ml oral solution of BI 1595043 concentrated 2.5 mg/mL (total dose: 160 mg BI 1595043) as single dose once daily with 240 mL of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Gastrointestinal disorders
Angular cheilitis
|
6.2%
1/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
6.2%
1/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
General disorders
Fatigue
|
0.00%
0/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
50.0%
3/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
16.7%
1/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
0.00%
0/6 • From drug administration until end of trial, up to 15 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER