Trial Outcomes & Findings for First in Man Trial of BI 113608 (NCT NCT01540825)

Last Updated: 2017-01-20

Results Overview

Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

80 participants

Primary outcome timeframe

From administration of study drug until end-of-study visit, up to 10 days

Results posted on

2017-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg Participants received a single dose of BI 113608 200mg powder for oral solution
Overall Study STARTED	20	6	6	6	6	6	6	6	6	6	6
Overall Study COMPLETED	20	6	6	6	6	6	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First in Man Trial of BI 113608

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=20 Participants Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 Participants Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 Participants Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 Participants Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 Participants Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 Participants Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 Participants Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 Participants Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 Participants Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 Participants Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg n=6 Participants Participants received a single dose of BI 113608 200mg powder for oral solution	Total n=80 Participants Total of all reporting groups
Age, Continuous	38.0 Years STANDARD_DEVIATION 10.0 • n=93 Participants	29.2 Years STANDARD_DEVIATION 8.1 • n=4 Participants	34.8 Years STANDARD_DEVIATION 6.4 • n=27 Participants	36.8 Years STANDARD_DEVIATION 12.8 • n=483 Participants	28.5 Years STANDARD_DEVIATION 9.5 • n=36 Participants	41.2 Years STANDARD_DEVIATION 4.6 • n=10 Participants	30.5 Years STANDARD_DEVIATION 9.6 • n=115 Participants	37.2 Years STANDARD_DEVIATION 11.8 • n=40 Participants	39.7 Years STANDARD_DEVIATION 11.7 • n=8 Participants	35.3 Years STANDARD_DEVIATION 11.3 • n=62 Participants	38.8 Years STANDARD_DEVIATION 9.2 • n=95 Participants	35.9 Years STANDARD_DEVIATION 10.0 • n=129 Participants
Gender 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	0 Participants n=40 Participants	0 Participants n=8 Participants	0 Participants n=62 Participants	0 Participants n=95 Participants	0 Participants n=129 Participants
Gender Male	20 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	6 Participants n=483 Participants	6 Participants n=36 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=40 Participants	6 Participants n=8 Participants	6 Participants n=62 Participants	6 Participants n=95 Participants	80 Participants n=129 Participants

PRIMARY outcome

Timeframe: From administration of study drug until end-of-study visit, up to 10 days

Population: Treated set

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 Participants Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 Participants Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 Participants Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 Participants Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 Participants Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 Participants Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 Participants Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 Participants Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 Participants Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg n=6 Participants Participants received a single dose of BI 113608 200mg powder for oral solution
Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: From administration of study drug until end-of-study visit, up to 10 days

Population: Treated set

Percentage of participants with drug-related adverse events

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 Participants Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 Participants Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 Participants Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 Participants Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 Participants Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 Participants Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 Participants Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 Participants Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 Participants Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg n=6 Participants Participants received a single dose of BI 113608 200mg powder for oral solution
Percentage of Participants With Drug-related Adverse Events	0.0 Percentage of participants	33.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	50.0 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants

PRIMARY outcome

Timeframe: End of study visit, up to day 10

Population: Treated set

Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 Participants Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 Participants Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 Participants Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 Participants Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 Participants Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 Participants Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 Participants Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 Participants Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 Participants Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg n=6 Participants Participants received a single dose of BI 113608 200mg powder for oral solution
Assessment of Tolerability by the Investigator Good	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Assessment of Tolerability by the Investigator Satisfactory	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Assessment of Tolerability by the Investigator Not satisfactory	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Assessment of Tolerability by the Investigator Bad	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Assessment of Tolerability by the Investigator Not assessable	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration

Population: PK set

Maximum measured concentration of the analyte in plasma (Cmax). The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 Participants Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 Participants Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 Participants Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 Participants Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 Participants Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 Participants Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 Participants Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 Participants Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 Participants Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg Participants received a single dose of BI 113608 200mg powder for oral solution
Cmax	1.36 nmol/L Geometric Coefficient of Variation 23.3 • Interval 0.5 to 1.0	1.66 nmol/L Geometric Coefficient of Variation 33.2 • Interval 0.5 to 1.0	2.83 nmol/L Geometric Coefficient of Variation 33.5 • Interval 0.25 to 4.0	7.33 nmol/L Geometric Coefficient of Variation 19.4 • Interval 0.75 to 4.0	23.5 nmol/L Geometric Coefficient of Variation 60.0 • Interval 0.5 to 4.0	52.6 nmol/L Geometric Coefficient of Variation 32.9 • Interval 0.25 to 4.0	202 nmol/L Geometric Coefficient of Variation 68.5 • Interval 0.25 to 6.0	459 nmol/L Geometric Coefficient of Variation 69.0 • Interval 0.5 to 2.0	984 nmol/L Geometric Coefficient of Variation 24.1 • Interval 0.75 to 1.52	1850 nmol/L Geometric Coefficient of Variation 16.4 • Interval 0.5 to 1.0	—

SECONDARY outcome

Population: PK set

Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 Participants Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 Participants Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 Participants Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 Participants Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 Participants Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 Participants Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 Participants Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 Participants Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 Participants Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg Participants received a single dose of BI 113608 200mg powder for oral solution
Tmax	0.63 Hours Interval 0.5 to 1.0	0.88 Hours Interval 0.5 to 1.0	2.25 Hours Interval 0.25 to 4.0	1.75 Hours Interval 0.75 to 4.0	1.00 Hours Interval 0.5 to 4.0	1.10 Hours Interval 0.25 to 4.0	0.76 Hours Interval 0.25 to 6.0	0.63 Hours Interval 0.5 to 2.0	0.75 Hours Interval 0.75 to 1.52	0.63 Hours Interval 0.5 to 1.0	—

SECONDARY outcome

Population: PK set

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 Participants Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 Participants Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 Participants Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 Participants Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 Participants Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 Participants Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 Participants Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 Participants Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 Participants Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg Participants received a single dose of BI 113608 200mg powder for oral solution
AUC0-tz	6.15 nmol*h/L Geometric Coefficient of Variation 23.7 • Interval 0.5 to 1.0	11.4 nmol*h/L Geometric Coefficient of Variation 62.3 • Interval 0.5 to 1.0	19.1 nmol*h/L Geometric Coefficient of Variation 30.7 • Interval 0.25 to 4.0	53.9 nmol*h/L Geometric Coefficient of Variation 18.3 • Interval 0.75 to 4.0	142 nmol*h/L Geometric Coefficient of Variation 24.2 • Interval 0.5 to 4.0	304 nmol*h/L Geometric Coefficient of Variation 24.7 • Interval 0.25 to 4.0	861 nmol*h/L Geometric Coefficient of Variation 34.8 • Interval 0.25 to 6.0	1990 nmol*h/L Geometric Coefficient of Variation 40.6 • Interval 0.5 to 2.0	4240 nmol*h/L Geometric Coefficient of Variation 18.2 • Interval 0.75 to 1.52	5950 nmol*h/L Geometric Coefficient of Variation 25.9 • Interval 0.5 to 1.0	—

SECONDARY outcome

Population: PK set

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 Participants Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 Participants Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 Participants Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 Participants Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 Participants Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 Participants Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 Participants Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 Participants Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 Participants Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg Participants received a single dose of BI 113608 200mg powder for oral solution
AUC0-infinity	6.54 nmol*h/L Geometric Coefficient of Variation 23.3 • Interval 0.5 to 1.0	12.2 nmol*h/L Geometric Coefficient of Variation 60.3 • Interval 0.5 to 1.0	19.9 nmol*h/L Geometric Coefficient of Variation 28.7 • Interval 0.25 to 4.0	55.2 nmol*h/L Geometric Coefficient of Variation 18.8 • Interval 0.75 to 4.0	144 nmol*h/L Geometric Coefficient of Variation 23.2 • Interval 0.5 to 4.0	307 nmol*h/L Geometric Coefficient of Variation 25.2 • Interval 0.25 to 4.0	862 nmol*h/L Geometric Coefficient of Variation 34.7 • Interval 0.25 to 6.0	1990 nmol*h/L Geometric Coefficient of Variation 40.6 • Interval 0.5 to 2.0	4250 nmol*h/L Geometric Coefficient of Variation 18.2 • Interval 0.75 to 1.52	5960 nmol*h/L Geometric Coefficient of Variation 25.9 • Interval 0.5 to 1.0	—

SECONDARY outcome

Population: PK set

Terminal half-life of the analyte in plasma (t1/2)

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 Participants Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 Participants Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 Participants Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 Participants Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 Participants Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 Participants Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 Participants Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 Participants Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 Participants Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg Participants received a single dose of BI 113608 200mg powder for oral solution
t1/2	4.66 Hours Geometric Coefficient of Variation 22.4 • Interval 0.5 to 1.0	8.10 Hours Geometric Coefficient of Variation 38.0 • Interval 0.5 to 1.0	8.56 Hours Geometric Coefficient of Variation 17.5 • Interval 0.25 to 4.0	8.08 Hours Geometric Coefficient of Variation 39.6 • Interval 0.75 to 4.0	10.3 Hours Geometric Coefficient of Variation 24.2 • Interval 0.5 to 4.0	9.51 Hours Geometric Coefficient of Variation 26.6 • Interval 0.25 to 4.0	11.2 Hours Geometric Coefficient of Variation 7.54 • Interval 0.25 to 6.0	12.8 Hours Geometric Coefficient of Variation 11.2 • Interval 0.5 to 2.0	12.5 Hours Geometric Coefficient of Variation 15.6 • Interval 0.75 to 1.52	11.8 Hours Geometric Coefficient of Variation 12.9 • Interval 0.5 to 1.0	—

Deaths: 0 deaths

BI 113608 200mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=20 participants at risk Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 participants at risk Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 participants at risk Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 participants at risk Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 participants at risk Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 participants at risk Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 participants at risk Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 participants at risk Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 participants at risk Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 participants at risk Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg n=6 participants at risk Participants received a single dose of BI 113608 200mg powder for oral solution
Nervous system disorders Retrograde amnesia	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Injury, poisoning and procedural complications Concussion	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Injury, poisoning and procedural complications Fall	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Injury, poisoning and procedural complications Laceration	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days

Other adverse events

Other adverse events
Measure	Placebo n=20 participants at risk Participants received a single dose of a placebo oral solution of volume matching the respective dose group	BI 113608 0.5mg n=6 participants at risk Participants received a single dose of BI 113608 0.5mg powder for oral solution	BI 113608 1mg n=6 participants at risk Participants received a single dose of BI 113608 1mg powder for oral solution	BI 113608 2mg n=6 participants at risk Participants received a single dose of BI 113608 2mg powder for oral solution	BI 113608 5mg n=6 participants at risk Participants received a single dose of BI 113608 5mg powder for oral solution	BI 113608 10mg n=6 participants at risk Participants received a single dose of BI 113608 10mg powder for oral solution	BI 113608 20mg n=6 participants at risk Participants received a single dose of BI 113608 20mg powder for oral solution	BI 113608 50mg n=6 participants at risk Participants received a single dose of BI 113608 50mg powder for oral solution	BI 113608 100mg n=6 participants at risk Participants received a single dose of BI 113608 100mg powder for oral solution	BI 113608 150mg n=6 participants at risk Participants received a single dose of BI 113608 150mg powder for oral solution	BI 113608 200mg n=6 participants at risk Participants received a single dose of BI 113608 200mg powder for oral solution
Gastrointestinal disorders Abdominal pain	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Gastrointestinal disorders Dyspepsia	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days
General disorders Fatigue	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days
General disorders Vessel puncture site haematoma	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Nervous system disorders Headache	5.0% 1/20 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	33.3% 2/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days
Nervous system disorders Syncope	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Renal and urinary disorders Urine odour abnormal	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	16.7% 1/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days	0.00% 0/6 • From administration of study drug until end-of-study visit, up to 10 days

Additional Information

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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.
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