To Assess Safety, Tolerability and Pharmacokinetics of BI... | NCT02706925

NCT02706925

Protocol Section

Identification Module

Results Section

Participant Flow Module

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

ID	Type	Description	Link
2015-004395-30	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
BI 443651	Experimental		Drug: BI 443651
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BI 443651	Drug		BI 443651
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Drug-related Adverse Events (AEs)	This outcome measure presents percentage of the subjects with drug-related AEs. The doses ranged from 10 μg to 3600 μg for the outcome measure [Percentage of subjects with drug-related Adverse Events (AEs)].	Up to 216 hours.

Secondary Outcomes

Measure	Description	Time Frame
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)	This outcome measure presents 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). Time frame note: The time points 72:00h, 96:00h below was only applicable for highest dose (and corresponding placebo subjects). Two blood sample for stability testing were taken at 3:00h time point from the Treatment C dose group only. The doses ranged from 10 μg to 3600 μg for the outcome measure [AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)].

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Healthy male according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 50 years (incl.)
BMI of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more 30 g per day for males)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant ECG finding at screening
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
The subject has a diagnosis history of pulmonary hyperreactivity.
Estimated glomerular filtration rate (eGFR) below 80 mL/min

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Humanpharmakologisches Zentrum Biberach		Biberach		88397	Germany

Arm/Group Information

ID	Title	Description
FG000	Placebo	Subjects were administered single dose of matching placebo to BI 443651 solution for inhalation per actuation via the RESPIMAT® inhaler orally.
FG001	BI 443651 10 μg	Subjects were administered single dose of BI 443651 10 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
FG002	BI 443651 30 μg	Subjects were administered single dose of BI 443651 30 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
FG003	BI 443651 100 μg	Subjects were administered single dose of BI 443651 100 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
FG004	BI 443651 300 μg	Subjects were administered single dose of BI 443651 300 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
FG005	BI 443651 900 μg	Subjects were administered single dose of BI 443651 900 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
FG006	BI 443651 1800 μg	Subjects were administered single dose of BI 443651 1800 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
FG007	BI 443651 2700 μg	Subjects were administered single dose of BI 443651 2700 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.
FG008	BI 443651 3600 μg	Subjects were administered single dose of BI 443651 3600 μg solution for inhalation per actuation via the RESPIMAT® inhaler orally.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Subjects were administered single dose of matching placebo to BI 443651 solution for inhalation per actuation via the RESPIMAT® inhaler orally.
BG001	BI 443651 10 μg

Units	Counts
Participants	BG000

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

Percentage of Subjects With Drug-related Adverse Events (AEs)

This outcome measure presents percentage of the subjects with drug-related AEs. The doses ranged from 10 μg to 3600 μg for the outcome measure [Percentage of subjects with drug-related Adverse Events (AEs)].

Treated Set (TS): This subject set includes all subjects from the Randomised Set (RS) who were documented to have taken at least 1 dose of study drug.

Posted

Number

Percentage of subjects

Up to 216 hours.

ID	Title	Description
OG000	Placebo	Subjects were administered single dose of matching placebo to BI 443651 solution for inhalation per actuation via the RESPIMAT® inhaler orally.
OG001	BI 443651 10 μg

Adverse Events Module

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	Subjects were administered single dose of matching placebo to BI 443651 solution for inhalation per actuation via the RESPIMAT® inhaler orally.