Trial Outcomes & Findings for This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men (NCT NCT03349723)
NCT ID: NCT03349723
Last Updated: 2022-04-11
Results Overview
Percentage of participants with drug-related adverse events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
From drug administration until end of trial examination, up to 9 days
Results posted on
2022-04-11
Participant Flow
This was single-blind, partially randomised, and placebo controlled within parallel dose groups trial. A total of 57 participants were entered and 56 were treated. The dose range for Treatment A to Treatment G was 3 μg to 1200 μg.
All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
3 Microgram BI 1265162
3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
10 Microgram BI 1265162
10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
30 Microgram BI 1265162
30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
100 Microgram BI 1265162
100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
300 Microgram BI 1265162
300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
600 Microgram BI 1265162
600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
1200 Microgram BI 1265162
1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
Placebo Matching BI 1265162
Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
14
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men
Baseline characteristics by cohort
| Measure |
3 Microgram BI 1265162
n=6 Participants
3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
10 Microgram BI 1265162
n=6 Participants
10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
30 Microgram BI 1265162
n=6 Participants
30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
100 Microgram BI 1265162
n=6 Participants
100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
300 Microgram BI 1265162
n=6 Participants
300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
600 Microgram BI 1265162
n=6 Participants
600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
1200 Microgram BI 1265162
n=6 Participants
1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
Placebo Matching BI 1265162
n=14 Participants
Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.3 Years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
31.8 Years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
28.7 Years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
44.7 Years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
32.0 Years
STANDARD_DEVIATION 7.3 • n=21 Participants
|
34.5 Years
STANDARD_DEVIATION 8.9 • n=8 Participants
|
38.8 Years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
35.1 Years
STANDARD_DEVIATION 11.0 • n=24 Participants
|
34.7 Years
STANDARD_DEVIATION 8.8 • n=42 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
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 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=8 Participants
|
6 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
56 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 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=8 Participants
|
6 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
55 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=42 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
|
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
|
0 Participants
n=42 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=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 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=8 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
55 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From drug administration until end of trial examination, up to 9 daysPopulation: Treated set(TS): This subject set included all subjects who had received at least 1 dose of trial medication.
Percentage of participants with drug-related adverse events (AEs).
Outcome measures
| Measure |
3 Microgram BI 1265162
n=6 Participants
3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
10 Microgram BI 1265162
n=6 Participants
10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
30 Microgram BI 1265162
n=6 Participants
30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
100 Microgram BI 1265162
n=6 Participants
100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
300 Microgram BI 1265162
n=6 Participants
300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
600 Microgram BI 1265162
n=6 Participants
600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
1200 Microgram BI 1265162
n=6 Participants
1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
Placebo Matching BI 1265162
n=14 Participants
Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Drug-related Adverse Events (AEs)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
16.7 Percentage of participants (%)
|
16.7 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
0 Percentage of participants (%)
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were taken pre-dose and 0:02 (hour: minute), 0:05, 0:10, 0:15, 0:20 , 0:30, 0:45, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 48:00 and 72:00 (Last time point only taken for 1200 µg) after drug administrationPopulation: The Pharmacokinetic set (PKS) included all subjects of the TS who received BI 1265162 and provided at least 1 PK parameter that was not excluded due to relevant protocol violations or due to PK non-evaluability.
Maximum measured concentration of BI 1265162 in plasma (Cmax).
Outcome measures
| Measure |
3 Microgram BI 1265162
n=6 Participants
3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
10 Microgram BI 1265162
n=6 Participants
10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
30 Microgram BI 1265162
n=6 Participants
30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
100 Microgram BI 1265162
n=6 Participants
100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
300 Microgram BI 1265162
n=6 Participants
300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
600 Microgram BI 1265162
n=6 Participants
600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
1200 Microgram BI 1265162
n=6 Participants
1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
Placebo Matching BI 1265162
Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1265162 in Plasma (Cmax)
|
17.8 Picomoles Per Litre (pmol/L)
Geometric Coefficient of Variation 32.9
|
50.1 Picomoles Per Litre (pmol/L)
Geometric Coefficient of Variation 46.6
|
129.0 Picomoles Per Litre (pmol/L)
Geometric Coefficient of Variation 40.1
|
462.0 Picomoles Per Litre (pmol/L)
Geometric Coefficient of Variation 53.2
|
1090.0 Picomoles Per Litre (pmol/L)
Geometric Coefficient of Variation 26.0
|
3130.0 Picomoles Per Litre (pmol/L)
Geometric Coefficient of Variation 30.6
|
6500.0 Picomoles Per Litre (pmol/L)
Geometric Coefficient of Variation 73.1
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were taken pre-dose and 0:02 (hour: minute), 0:05, 0:10, 0:15, 0:20 , 0:30, 0:45, 1:00 after drug administrationPopulation: The Pharmacokinetic set (PKS) included all subjects of the TS who received BI 1265162 and provided at least 1 PK parameter that was not excluded due to relevant protocol violations or due to PK non-evaluability. Only subjects with non-missing values were included in the analyses.
Area under the concentration-time curve of the BI 1265162 in plasma over the time interval 0 to 1 hour post-dose (AUC0-1)
Outcome measures
| Measure |
3 Microgram BI 1265162
n=5 Participants
3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
10 Microgram BI 1265162
n=6 Participants
10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
30 Microgram BI 1265162
n=6 Participants
30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
100 Microgram BI 1265162
n=6 Participants
100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
300 Microgram BI 1265162
n=6 Participants
300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
600 Microgram BI 1265162
n=6 Participants
600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
1200 Microgram BI 1265162
n=6 Participants
1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
Placebo Matching BI 1265162
Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the BI 1265162 in Plasma Over the Time Interval 0 to 1 Hour Post-dose (AUC0-1)
|
10.4 Picomoles*Hour Per Litre (pmol*h/L)
Geometric Coefficient of Variation 42.4
|
28.7 Picomoles*Hour Per Litre (pmol*h/L)
Geometric Coefficient of Variation 49.0
|
73.7 Picomoles*Hour Per Litre (pmol*h/L)
Geometric Coefficient of Variation 43.4
|
299.0 Picomoles*Hour Per Litre (pmol*h/L)
Geometric Coefficient of Variation 45.2
|
706.0 Picomoles*Hour Per Litre (pmol*h/L)
Geometric Coefficient of Variation 25.9
|
1700.0 Picomoles*Hour Per Litre (pmol*h/L)
Geometric Coefficient of Variation 34.5
|
3920.0 Picomoles*Hour Per Litre (pmol*h/L)
Geometric Coefficient of Variation 76.4
|
—
|
Adverse Events
3 Microgram BI 1265162
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10 Microgram BI 1265162
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30 Microgram BI 1265162
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
100 Microgram BI 1265162
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
300 Microgram BI 1265162
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
600 Microgram BI 1265162
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1200 Microgram BI 1265162
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Matching BI 1265162
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 |
3 Microgram BI 1265162
n=6 participants at risk
3 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
10 Microgram BI 1265162
n=6 participants at risk
10 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
30 Microgram BI 1265162
n=6 participants at risk
30 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
100 Microgram BI 1265162
n=6 participants at risk
100 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
300 Microgram BI 1265162
n=6 participants at risk
300 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
600 Microgram BI 1265162
n=6 participants at risk
600 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
1200 Microgram BI 1265162
n=6 participants at risk
1200 microgram BI 1265162 solution for inhalation was administered orally via Respimat® inhaler.
|
Placebo Matching BI 1265162
n=14 participants at risk
Subjects administered single dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® inhaler.
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
16.7%
1/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/14 • From drug administration until end of trial examination, up to 9 days.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
16.7%
1/6 • From drug administration until end of trial examination, up to 9 days.
|
7.1%
1/14 • From drug administration until end of trial examination, up to 9 days.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
16.7%
1/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
16.7%
1/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
7.1%
1/14 • From drug administration until end of trial examination, up to 9 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
16.7%
1/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/6 • From drug administration until end of trial examination, up to 9 days.
|
0.00%
0/14 • From drug administration until end of trial examination, up to 9 days.
|
Additional Information
Boehringer Ingelheim, Call Center
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