First in Man Trial of BI 113608

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01540825

Enrollment

Registered

2012-02-29

Start date

2012-02-29

Completion date

2012-05-31

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses. A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Interventions

DRUGBI 113608

Low dose powder for oral solution

DRUGPlacebo

Powder for oral solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1\. Healthy male subjects

Exclusion criteria

1\. Any relevant deviation from healthy conditions

Design outcomes

Primary

Measure	Time frame	Description
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	From administration of study drug until end-of-study visit, up to 10 days	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
Percentage of Participants With Drug-related Adverse Events	From administration of study drug until end-of-study visit, up to 10 days	Percentage of participants with drug-related adverse events
Assessment of Tolerability by the Investigator	End of study visit, up to day 10	Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.

Secondary

Measure	Time frame	Description
AUC0-infinity	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	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)
Cmax	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	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.
t1/2	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	Terminal half-life of the analyte in plasma (t1/2)
Tmax	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	Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)
AUC0-tz	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	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)

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Placebo Participants received a single dose of a placebo oral solution of volume matching the respective dose group	20
BI 113608 0.5mg Participants received a single dose of BI 113608 0.5mg powder for oral solution	6
BI 113608 1mg Participants received a single dose of BI 113608 1mg powder for oral solution	6
BI 113608 2mg Participants received a single dose of BI 113608 2mg powder for oral solution	6
BI 113608 5mg Participants received a single dose of BI 113608 5mg powder for oral solution	6
BI 113608 10mg Participants received a single dose of BI 113608 10mg powder for oral solution	6
BI 113608 20mg Participants received a single dose of BI 113608 20mg powder for oral solution	6
BI 113608 50mg Participants received a single dose of BI 113608 50mg powder for oral solution	6
BI 113608 100mg Participants received a single dose of BI 113608 100mg powder for oral solution	6
BI 113608 150mg Participants received a single dose of BI 113608 150mg powder for oral solution	6
BI 113608 200mg Participants received a single dose of BI 113608 200mg powder for oral solution	6
Total	80

Baseline characteristics

Characteristic	Placebo	BI 113608 0.5mg	BI 113608 1mg	BI 113608 2mg	BI 113608 5mg	BI 113608 10mg	BI 113608 20mg	BI 113608 50mg	BI 113608 100mg	BI 113608 150mg	BI 113608 200mg	Total
Age, Continuous	38.0 Years STANDARD_DEVIATION 10	29.2 Years STANDARD_DEVIATION 8.1	34.8 Years STANDARD_DEVIATION 6.4	36.8 Years STANDARD_DEVIATION 12.8	28.5 Years STANDARD_DEVIATION 9.5	41.2 Years STANDARD_DEVIATION 4.6	30.5 Years STANDARD_DEVIATION 9.6	37.2 Years STANDARD_DEVIATION 11.8	39.7 Years STANDARD_DEVIATION 11.7	35.3 Years STANDARD_DEVIATION 11.3	38.8 Years STANDARD_DEVIATION 9.2	35.9 Years STANDARD_DEVIATION 10
Gender Female	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Gender Male	20 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	80 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	2 / 20	3 / 6	1 / 6	1 / 6	0 / 6	3 / 6	0 / 6	0 / 6	4 / 6	0 / 6	2 / 6
serious Total, serious adverse events	0 / 20	0 / 6	0 / 6	0 / 6	0 / 6	1 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6

Outcome results

Primary

Assessment of Tolerability by the Investigator

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

Time frame: End of study visit, up to day 10

Population: Treated set

Arm	Measure	Group	Value (NUMBER)
Placebo	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
Placebo	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
Placebo	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
Placebo	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
Placebo	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 0.5mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 0.5mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 0.5mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 0.5mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 0.5mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 1mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 1mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 1mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 1mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 1mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 2mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 2mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 2mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 2mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 2mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 5mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 5mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 5mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 5mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 5mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 10mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 10mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 10mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 10mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 10mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 20mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 20mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 20mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 20mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 20mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 50mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 50mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 50mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 50mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 50mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 100mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 100mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 100mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 100mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 100mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 150mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants
BI 113608 150mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 150mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 150mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 150mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 200mg	Assessment of Tolerability by the Investigator	Bad	0 Percentage of participants
BI 113608 200mg	Assessment of Tolerability by the Investigator	Not assessable	0 Percentage of participants
BI 113608 200mg	Assessment of Tolerability by the Investigator	Satisfactory	0 Percentage of participants
BI 113608 200mg	Assessment of Tolerability by the Investigator	Good	100 Percentage of participants
BI 113608 200mg	Assessment of Tolerability by the Investigator	Not satisfactory	0 Percentage of participants

Primary

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

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

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

Population: Treated set

Arm	Measure	Value (NUMBER)
Placebo	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
BI 113608 0.5mg	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
BI 113608 1mg	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
BI 113608 2mg	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
BI 113608 5mg	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
BI 113608 10mg	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
BI 113608 20mg	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
BI 113608 50mg	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
BI 113608 100mg	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
BI 113608 150mg	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
BI 113608 200mg	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

Primary

Percentage of Participants With Drug-related Adverse Events

Percentage of participants with drug-related adverse events

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

Population: Treated set

Arm	Measure	Value (NUMBER)
Placebo	Percentage of Participants With Drug-related Adverse Events	0.0 Percentage of participants
BI 113608 0.5mg	Percentage of Participants With Drug-related Adverse Events	33.3 Percentage of participants
BI 113608 1mg	Percentage of Participants With Drug-related Adverse Events	0.0 Percentage of participants
BI 113608 2mg	Percentage of Participants With Drug-related Adverse Events	0.0 Percentage of participants
BI 113608 5mg	Percentage of Participants With Drug-related Adverse Events	0.0 Percentage of participants
BI 113608 10mg	Percentage of Participants With Drug-related Adverse Events	0.0 Percentage of participants
BI 113608 20mg	Percentage of Participants With Drug-related Adverse Events	0.0 Percentage of participants
BI 113608 50mg	Percentage of Participants With Drug-related Adverse Events	0.0 Percentage of participants
BI 113608 100mg	Percentage of Participants With Drug-related Adverse Events	50.0 Percentage of participants
BI 113608 150mg	Percentage of Participants With Drug-related Adverse Events	0.0 Percentage of participants
BI 113608 200mg	Percentage of Participants With Drug-related Adverse Events	33.3 Percentage of participants

Secondary

AUC0-infinity

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

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo	AUC0-infinity	6.54 nmol*h/L	Geometric Coefficient of Variation 23.3
BI 113608 0.5mg	AUC0-infinity	12.2 nmol*h/L	Geometric Coefficient of Variation 60.3
BI 113608 1mg	AUC0-infinity	19.9 nmol*h/L	Geometric Coefficient of Variation 28.7
BI 113608 2mg	AUC0-infinity	55.2 nmol*h/L	Geometric Coefficient of Variation 18.8
BI 113608 5mg	AUC0-infinity	144 nmol*h/L	Geometric Coefficient of Variation 23.2
BI 113608 10mg	AUC0-infinity	307 nmol*h/L	Geometric Coefficient of Variation 25.2
BI 113608 20mg	AUC0-infinity	862 nmol*h/L	Geometric Coefficient of Variation 34.7
BI 113608 50mg	AUC0-infinity	1990 nmol*h/L	Geometric Coefficient of Variation 40.6
BI 113608 100mg	AUC0-infinity	4250 nmol*h/L	Geometric Coefficient of Variation 18.2
BI 113608 150mg	AUC0-infinity	5960 nmol*h/L	Geometric Coefficient of Variation 25.9

Comparison: This was non confirmatory testing (Single dose).Dose proportionality of BI 113608 (PIB) for AUC0-inf was analysed95% CI: [1.108, 1.1941]

Secondary

AUC0-tz

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)

Population: PK set

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo	AUC0-tz	6.15 nmol*h/L	Geometric Coefficient of Variation 23.7
BI 113608 0.5mg	AUC0-tz	11.4 nmol*h/L	Geometric Coefficient of Variation 62.3
BI 113608 1mg	AUC0-tz	19.1 nmol*h/L	Geometric Coefficient of Variation 30.7
BI 113608 2mg	AUC0-tz	53.9 nmol*h/L	Geometric Coefficient of Variation 18.3
BI 113608 5mg	AUC0-tz	142 nmol*h/L	Geometric Coefficient of Variation 24.2
BI 113608 10mg	AUC0-tz	304 nmol*h/L	Geometric Coefficient of Variation 24.7
BI 113608 20mg	AUC0-tz	861 nmol*h/L	Geometric Coefficient of Variation 34.8
BI 113608 50mg	AUC0-tz	1990 nmol*h/L	Geometric Coefficient of Variation 40.6
BI 113608 100mg	AUC0-tz	4240 nmol*h/L	Geometric Coefficient of Variation 18.2
BI 113608 150mg	AUC0-tz	5950 nmol*h/L	Geometric Coefficient of Variation 25.9

Comparison: This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (PIB) for AUC 0- tz was analysed.95% CI: [1.1195, 1.2057]

Secondary

Cmax

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.

Population: PK set

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo	Cmax	1.36 nmol/L	Geometric Coefficient of Variation 23.3
BI 113608 0.5mg	Cmax	1.66 nmol/L	Geometric Coefficient of Variation 33.2
BI 113608 1mg	Cmax	2.83 nmol/L	Geometric Coefficient of Variation 33.5
BI 113608 2mg	Cmax	7.33 nmol/L	Geometric Coefficient of Variation 19.4
BI 113608 5mg	Cmax	23.5 nmol/L	Geometric Coefficient of Variation 60
BI 113608 10mg	Cmax	52.6 nmol/L	Geometric Coefficient of Variation 32.9
BI 113608 20mg	Cmax	202 nmol/L	Geometric Coefficient of Variation 68.5
BI 113608 50mg	Cmax	459 nmol/L	Geometric Coefficient of Variation 69
BI 113608 100mg	Cmax	984 nmol/L	Geometric Coefficient of Variation 24.1
BI 113608 150mg	Cmax	1850 nmol/L	Geometric Coefficient of Variation 16.4

Comparison: This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (powder in bottle (PIB)) for Cmax was analysed.95% CI: [1.1831, 1.3112]

Secondary

t1/2

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

Population: PK set

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Placebo	t1/2	4.66 Hours	Geometric Coefficient of Variation 22.4
BI 113608 0.5mg	t1/2	8.10 Hours	Geometric Coefficient of Variation 38
BI 113608 1mg	t1/2	8.56 Hours	Geometric Coefficient of Variation 17.5
BI 113608 2mg	t1/2	8.08 Hours	Geometric Coefficient of Variation 39.6
BI 113608 5mg	t1/2	10.3 Hours	Geometric Coefficient of Variation 24.2
BI 113608 10mg	t1/2	9.51 Hours	Geometric Coefficient of Variation 26.6
BI 113608 20mg	t1/2	11.2 Hours	Geometric Coefficient of Variation 7.54
BI 113608 50mg	t1/2	12.8 Hours	Geometric Coefficient of Variation 11.2
BI 113608 100mg	t1/2	12.5 Hours	Geometric Coefficient of Variation 15.6
BI 113608 150mg	t1/2	11.8 Hours	Geometric Coefficient of Variation 12.9

Secondary

Tmax

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

Population: PK set

Arm	Measure	Value (MEDIAN)
Placebo	Tmax	0.63 Hours
BI 113608 0.5mg	Tmax	0.88 Hours
BI 113608 1mg	Tmax	2.25 Hours
BI 113608 2mg	Tmax	1.75 Hours
BI 113608 5mg	Tmax	1.00 Hours
BI 113608 10mg	Tmax	1.10 Hours
BI 113608 20mg	Tmax	0.76 Hours
BI 113608 50mg	Tmax	0.63 Hours
BI 113608 100mg	Tmax	0.75 Hours
BI 113608 150mg	Tmax	0.63 Hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

First in Man Trial of BI 113608

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Assessment of Tolerability by the Investigator

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

Percentage of Participants With Drug-related Adverse Events

AUC0-infinity

AUC0-tz

Cmax

t1/2

Tmax