Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 96

Inclusion Criteria

Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
Age ≥21 and ≤50 years
Body mass index (BMI) ≥18.5 and <30 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria

Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
Evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
Participation in another trial with an investigational drug within 2 months prior to randomisation
Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to refrain from smoking on trial days as judged by the investigator
Alcohol abuse (more than 40 g alcohol a day)
Drug abuse
Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
Excessive physical activities within 1 week prior to randomisation or during the trial
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of the study centre

The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:

Asthma or history of pulmonary hyperreactivity
Hyperthyrosis
Allergic rhinitis in need of treatment
Clinically relevant cardiac arrhythmia
Paroxysmal tachycardia (>100 beats per minute)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 11054 CL	BI 11054 CL	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Airway resistance (Raw)	up to 24 hours after drug administration	measured by body plethysmography
Number of subjects with clinically significant findings in physical examination	up to 18 days after drug administration
Number of subjects with clinically significant findings in additional safety laboratory tests	up to 24 hours after drug administration	cyclic adenosine monophosphate (cAMP) and potassium
Number of subjects with findings of pulmonary auscultation	up to 24 hours after drug administration
Number of subjects with clinically significant findings in vital signs	up to 18 days after drug administration	blood pressure (BP), pulse rate (PR), respiratory rate (RR)
Global tolerability assessed by investigator on a 4-point scale	up to 18 days after drug administration
Number of subjects with clinically significant findings in orthostasis tests	up to 24 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests	up to 18 days after drug administration
Number of subjects with adverse events	up to 18 days after drug administration
Number of subjects with clinically significant changes in body temperature	up to 24 hours after drug administration
Number of subjects with clinically significant findings in electrocardiogram (ECG)	up to 18 days after drug administration
Number of subjects with findings of oropharyngeal inspection	up to 24 hours after drug administration

Secondary Outcome Measures

Name	Time	Method
tmax (time from dosing to maximum measured concentration)	up to 96 hours
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)	up to 96 hours
Cmax (maximum measured concentration of the analyte in plasma)	up to 96 hours
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration)	up to 96 hours
MRTih (mean residence time of the analyte in the body after inhalation)	up to 96 hours
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time t1 to time t2)	up to 96 hours
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 96 hours
%AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation)	up to 96 hours
CL/F (apparent clearance of the analyte in plasma after extravascular administration)	up to 96 hours
λz (terminal rate constant in plasma)	up to 96 hours
t1/2 (terminal half-life of the analyte in plasma)	up to 96 hours
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)	up to 96 hours
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)	up to 96 hours
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)	up to 96 hours

Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers

Recruitment & Eligibility

Study & Design

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