First in Man Trial of BI 113608 | NCT01540825 | Trialant
NCT01540825
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Jan 20, 2017Estimated
Enrollment
80Actual
Phase
Phase 1
Conditions
Healthy
Interventions
BI 113608
BI 113608
BI 113608
BI 113608
Placebo
BI 113608
BI 113608
BI 113608
BI 113608
BI 113608
BI 113608
Countries
Germany
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01540825
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1314.1
Secondary IDs
ID
Type
Description
Link
2011-005034-19
EudraCT Number
EudraCT
Brief Title
First in Man Trial of BI 113608
Official Title
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Nov 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2012
Primary Completion Date
May 2012Actual
Completion Date
May 2012Actual
First Submitted Date
Feb 13, 2012
First Submission Date that Met QC Criteria
Feb 23, 2012
First Posted Date
Feb 29, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 23, 2016
Results First Submitted that Met QC Criteria
Nov 23, 2016
Results First Posted Date
Jan 20, 2017Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 23, 2016
Last Update Posted Date
Jan 20, 2017Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
80Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
BI 113608 high dose 1
Experimental
Powder for oral solution
Drug: BI 113608
BI 113608 low dose 1
Experimental
Powder for oral solution
Drug: BI 113608
BI 113608 low dose 2
Experimental
Powder for oral solution
Drug: BI 113608
BI 113608 low dose 4
Experimental
Powder for oral solution
Drug: BI 113608
BI 113608 low dose 5
Experimental
Powder for oral solution
Drug: BI 113608
BI 113608 medium dose 1
Experimental
Powder for oral solution
Drug: BI 113608
BI 113608 medium dose 2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BI 113608
Drug
Low dose powder for oral solution
BI 113608 low dose 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
From administration of study drug until end-of-study visit, up to 10 days
Percentage of Participants With Drug-related Adverse Events
Percentage of participants with drug-related adverse events
From administration of study drug until end-of-study visit, up to 10 days
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.
End of study visit, up to day 10
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
1. Healthy male subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
Accepts Healthy Volunteers
Yes
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
50 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Boehringer Ingelheim Investigational Site
Mannheim
Germany
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received a single dose of a placebo oral solution of volume matching the respective dose group
FG001
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
FG002
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
FG003
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
FG004
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
FG005
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
FG006
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
FG007
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
FG008
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
FG009
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
FG010
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00020 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0066 subjects
FG0076 subjects
FG0086 subjects
FG0096 subjects
FG0106 subjects
COMPLETED
FG00020 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline Characteristics Module
Baseline Analysis Population Description
Treated set which included all randomised subjects who received 1 dose of the study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received a single dose of a placebo oral solution of volume matching the respective dose group
BG001
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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
Treated set
Posted
Number
Percentage of participants
From administration of study drug until end-of-study visit, up to 10 days
ID
Title
Description
OG000
Placebo
Participants received a single dose of a placebo oral solution of volume matching the respective dose group
OG001
Adverse Events Module
Frequency Threshold
5
Time Frame
From administration of study drug until end-of-study visit, up to 10 days
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received a single dose of a placebo oral solution of volume matching the respective dose group
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Retrograde amnesia
Nervous system disorders
MedDRA 15.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
Not provided
Experimental
Powder for oral solution
Drug: BI 113608
BI 113608 medium dose 3
Experimental
Powder for oral solution
Drug: BI 113608
BI 113608 high dose 2
Experimental
Powder for oral solution
Drug: BI 113608
BI 113608 high dose 3
Experimental
Powder for oral solution
Drug: BI 113608
Placebo
Placebo Comparator
Powder for oral solution
Drug: Placebo
BI 113608
Drug
High dose powder for oral solution
BI 113608 high dose 1
BI 113608
Drug
Medium dose powder for oral solution
BI 113608 medium dose 3
BI 113608
Drug
Low dose powder for oral solution
BI 113608 low dose 2
Placebo
Drug
Powder for oral solution
Placebo
BI 113608
Drug
Low dose powder for oral solution
BI 113608 low dose 5
BI 113608
Drug
High dose powder for oral solution
BI 113608 high dose 2
BI 113608
Drug
High dose powder for oral solution
BI 113608 high dose 3
BI 113608
Drug
Medium dose powder for oral solution
BI 113608 medium dose 1
BI 113608
Drug
Medium dose powder for oral solution
BI 113608 medium dose 2
BI 113608
Drug
Low dose powder for oral solution
BI 113608 low dose 4
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
Tmax
Time from dosing to maximum measured concentration of the analyte in plasma (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
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)
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
AUC0-infinity
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (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
t1/2
Terminal half-life of the analyte in plasma (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
6 subjects
FG0056 subjects
FG0066 subjects
FG0076 subjects
FG0086 subjects
FG0096 subjects
FG0106 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
BG002
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
BG003
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
BG004
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
BG005
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
BG006
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
BG007
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
BG008
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
BG009
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
BG010
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
BG011
Total
Total of all reporting groups
20
BG0016
BG0026
BG0036
BG0046
BG0056
BG0066
BG0076
BG0086
BG0096
BG0106
BG01180
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00038.0± 10.0
BG00129.2± 8.1
BG00234.8± 6.4
BG00336.8± 12.8
BG00428.5± 9.5
BG00541.2± 4.6
BG00630.5± 9.6
BG00737.2± 11.8
BG00839.7± 11.7
BG00935.3± 11.3
BG01038.8± 9.2
BG01135.9± 10.0
Gender
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Male
BG00020
BG0016
BG0026
BG0036
BG004
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
OG002
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
OG003
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
OG004
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
OG005
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
OG006
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
OG007
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
OG008
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
OG009
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
OG010
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
Units
Counts
Participants
OG00020
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
OG0086
OG0096
OG0106
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
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.
PK set
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
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
ID
Title
Description
OG000
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
OG001
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
OG002
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
OG003
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
OG004
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
OG005
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
OG006
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
OG007
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
OG008
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
OG009
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.36± 23.3(0.50 to 1.00)
OG0011.66± 33.2(0.50 to 1.00)
OG0022.83± 33.5(0.25 to 4.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (powder in bottle (PIB)) for Cmax was analysed.
Slope
1.2472
Standard Error of the Mean
0.0320
2-Sided
95
1.1831
1.3112
Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope
No
Secondary
Tmax
Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)
PK set
Posted
Median
Full Range
Hours
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
ID
Title
Description
OG000
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
OG001
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
OG002
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
OG003
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
OG004
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
OG005
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
OG006
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
OG007
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
OG008
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
OG009
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.63(0.50 to 1.00)
OG0010.88(0.50 to 1.00)
OG0022.25(0.25 to 4.00)
OG003
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)
PK set
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol*h/L
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
ID
Title
Description
OG000
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
OG001
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
OG002
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
OG003
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
OG004
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
OG005
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
OG006
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
OG007
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
OG008
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
OG009
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.15± 23.7(0.50 to 1.00)
OG00111.4± 62.3(0.50 to 1.00)
OG00219.1± 30.7(0.25 to 4.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (PIB) for AUC 0- tz was analysed.
Slope
1.1626
Standard Error of the Mean
0.0215
2-Sided
95
1.1195
1.2057
Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope
No
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)
PK set
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol*h/L
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
ID
Title
Description
OG000
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
OG001
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
OG002
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
OG003
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
OG004
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
OG005
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
OG006
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
OG007
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
OG008
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
OG009
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.54± 23.3(0.50 to 1.00)
OG00112.2± 60.3(0.50 to 1.00)
OG00219.9± 28.7(0.25 to 4.00)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
This was non confirmatory testing (Single dose).Dose proportionality of BI 113608 (PIB) for AUC0-inf was analysed
Slope
1.1510
Standard Error of the Mean
0.0215
2-Sided
95
1.1080
1.1941
Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope
No
Secondary
t1/2
Terminal half-life of the analyte in plasma (t1/2)
PK set
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
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
ID
Title
Description
OG000
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
OG001
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
OG002
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
OG003
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
OG004
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
OG005
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
OG006
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
OG007
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
OG008
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
OG009
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.66± 22.4(0.50 to 1.00)
OG0018.10± 38.0(0.50 to 1.00)
OG0028.56± 17.5(0.25 to 4.00)
Primary
Percentage of Participants With Drug-related Adverse Events
Percentage of participants with drug-related adverse events
Treated set
Posted
Number
Percentage of participants
From administration of study drug until end-of-study visit, up to 10 days
ID
Title
Description
OG000
Placebo
Participants received a single dose of a placebo oral solution of volume matching the respective dose group
OG001
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
OG002
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
OG003
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
OG004
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
OG005
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
OG006
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
OG007
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
OG008
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
OG009
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
OG010
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
Units
Counts
Participants
OG00020
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG00133.3
OG0020.0
OG003
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.
Treated set
Posted
Number
Percentage of participants
End of study visit, up to day 10
ID
Title
Description
OG000
Placebo
Participants received a single dose of a placebo oral solution of volume matching the respective dose group
OG001
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
OG002
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
OG003
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
OG004
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
OG005
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
OG006
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
OG007
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
OG008
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
OG009
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
OG010
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
Units
Counts
Participants
OG00020
OG0016
OG0026
OG003
Title
Denominators
Categories
Good
Title
Measurements
OG000100
OG001100
OG002100
OG003
0
20
2
20
EG001
BI 113608 0.5mg
Participants received a single dose of BI 113608 0.5mg powder for oral solution
0
6
3
6
EG002
BI 113608 1mg
Participants received a single dose of BI 113608 1mg powder for oral solution
0
6
1
6
EG003
BI 113608 2mg
Participants received a single dose of BI 113608 2mg powder for oral solution
0
6
1
6
EG004
BI 113608 5mg
Participants received a single dose of BI 113608 5mg powder for oral solution
0
6
0
6
EG005
BI 113608 10mg
Participants received a single dose of BI 113608 10mg powder for oral solution
1
6
3
6
EG006
BI 113608 20mg
Participants received a single dose of BI 113608 20mg powder for oral solution
0
6
0
6
EG007
BI 113608 50mg
Participants received a single dose of BI 113608 50mg powder for oral solution
0
6
0
6
EG008
BI 113608 100mg
Participants received a single dose of BI 113608 100mg powder for oral solution
0
6
4
6
EG009
BI 113608 150mg
Participants received a single dose of BI 113608 150mg powder for oral solution
0
6
0
6
EG010
BI 113608 200mg
Participants received a single dose of BI 113608 200mg powder for oral solution
0
6
2
6
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Concussion
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected6 at risk
Fatigue
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0101 affected6 at risk
Vessel puncture site haematoma
General disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Periorbital haematoma
Injury, poisoning and procedural complications
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Headache
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0082 affected6 at risk
EG0090 affected6 at risk
EG0101 affected6 at risk
Syncope
Nervous system disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Urine odour abnormal
Renal and urinary disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected6 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.