Trial Outcomes & Findings for This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated. (NCT NCT03576144)

NCT ID: NCT03576144

Last Updated: 2022-02-23

Results Overview

Percentage of participants with drug-related adverse events (AEs).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

50 participants

Primary outcome timeframe

From first drug administration until 2 days after last drug administration, up to 10 days.

Results posted on

2022-02-23

Participant Flow

This Multiple rising dose (MRD) trial was designed as double-blind, randomised, and placebo-controlled within parallel dose groups.

All participants were screened for eligibility to participate in the trial. Participants attended a specialist site 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

Participant milestones
Measure	Placebo Matching BI 1265162 Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.	10 Microgram (μg) BI 1265162 Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.	30 μg BI 1265162 Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.	100 μg BI 1265162 Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.	300 μg BI 1265162 Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.	600 μg BI 1265162 Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
Overall Study STARTED	10	8	8	8	8	8
Overall Study COMPLETED	10	8	8	8	8	8
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Matching BI 1265162 n=10 Participants Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.	10 Microgram (μg) BI 1265162 n=8 Participants Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.	30 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.	100 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.	300 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.	600 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.	Total n=50 Participants Total of all reporting groups
Age, Continuous	33.4 Years STANDARD_DEVIATION 6.9 • n=93 Participants	34.0 Years STANDARD_DEVIATION 4.7 • n=4 Participants	27.6 Years STANDARD_DEVIATION 6.6 • n=27 Participants	33.9 Years STANDARD_DEVIATION 5.6 • n=483 Participants	32.4 Years STANDARD_DEVIATION 6.8 • n=36 Participants	35.5 Years STANDARD_DEVIATION 7.6 • n=10 Participants	32.8 Years STANDARD_DEVIATION 6.6 • n=115 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	8 Participants n=483 Participants	8 Participants n=36 Participants	8 Participants n=10 Participants	50 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	8 Participants n=483 Participants	8 Participants n=36 Participants	8 Participants n=10 Participants	49 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	7 Participants n=483 Participants	7 Participants n=36 Participants	8 Participants n=10 Participants	48 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: From first drug administration until 2 days after last drug administration, up to 10 days.

Population: Treated set (TS): The TS included included all participants who received at least 1 dose of trial drug. This was the full analysis set population in the sense of International council for harmonisation - efficacy guideline 9: statistical principles for clinical trials (ICH-E9).

Percentage of participants with drug-related adverse events (AEs).

Outcome measures

Outcome measures
Measure	Placebo Matching BI 1265162 n=10 Participants Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.	10 Microgram (μg) BI 1265162 n=8 Participants Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.	30 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.	100 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.	300 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.	600 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
Percentage of Participants With Drug-related Adverse Events (AEs)	0.0 Percentage of participants (%)	12.5 Percentage of participants (%)	12.5 Percentage of participants (%)	50.0 Percentage of participants (%)	50.0 Percentage of participants (%)	12.5 Percentage of participants (%)

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken within 1:30 hour:minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20 , 0:40, 1:00, 2:00, 4:00, 8:00 and 12:00 h:m after dosing on day 1.

Population: Pharmacokinetic parameter set (PKS): This subject set included all subjects in the TS who provided at least 1 PK parameter that was not excluded because of protocol deviations relevant to the statistical evaluation of Pharmacokinetic (PK) endpoints.

Area under the concentration-time curve of the BI 1265162 in plasma over the time interval of 0 to 12 hour (h) after administration of the first dose (AUC0-12).

Outcome measures

Outcome measures
Measure	Placebo Matching BI 1265162 n=8 Participants Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.	10 Microgram (μg) BI 1265162 n=8 Participants Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.	30 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.	100 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.	300 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.	600 μg BI 1265162 Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
Area Under the Concentration-time Curve of the BI 1265162 in Plasma Over the Time Interval of 0 to 12 Hour (h) After Administration of the First Dose (AUC0-12)	82.5 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 24.5	226 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 23.2	734 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 22.5	2430 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 35.2	6320 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 21.3	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken within 1:30 hour: minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 8:00, 12:00 and 24:00 h:m after dosing on day 1.

Population: PKS

Maximum measured concentration of the BI 1265162 in plasma after administration of the first dose (Cmax).

Outcome measures

Outcome measures
Measure	Placebo Matching BI 1265162 n=8 Participants Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.	10 Microgram (μg) BI 1265162 n=8 Participants Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.	30 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.	100 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.	300 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.	600 μg BI 1265162 Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
Maximum Measured Concentration of the BI 1265162 in Plasma After Administration of the First Dose (Cmax)	55.2 Picomoles Per Litre (pmol/L) Geometric Coefficient of Variation 36.1	158 Picomoles Per Litre (pmol/L) Geometric Coefficient of Variation 27.4	391 Picomoles Per Litre (pmol/L) Geometric Coefficient of Variation 24.4	1330 Picomoles Per Litre (pmol/L) Geometric Coefficient of Variation 43.5	4000 Picomoles Per Litre (pmol/L) Geometric Coefficient of Variation 28.0	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken 0:05 hour: minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 8:00 and 12:00 h:m after last dosing on day 8.

Population: PKS

Area under the concentration-time curve of the BI 1265162 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).

Outcome measures

Outcome measures
Measure	Placebo Matching BI 1265162 n=8 Participants Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily.	10 Microgram (μg) BI 1265162 n=8 Participants Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily.	30 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily.	100 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily.	300 μg BI 1265162 n=8 Participants Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily.	600 μg BI 1265162 Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily.
Area Under the Concentration-time Curve of the BI 1265162 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)	104 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 18.8	284 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 40.0	1190 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 29.4	3800 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 29.3	7010 PicomolesHour Per Litre (pmolh/L) Geometric Coefficient of Variation 36.4	—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken 0:05 hour: minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 8:00 and 12:00 h:m after last dosing on day 8.

Population: PKS

Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss).