Multiple Rising Inhalative Doses of BI 1744 CL in Healthy Male Volunteers

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 36

Inclusion Criteria

Healthy Japanese men: According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
Age ≥20 and ≤35 years
Body mass index (BMI) ≥18.5 and ≤25.0 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Subjects must be able to inhale medication in a competent manner from the Respimat®inhaler

Exclusion Criteria

Any finding of the medical examination (including ,blood pressure and pulse rate and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
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 drug or its excipients)
Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug before drug administration or during the trial
Use of prescription or non-prescription drugs within 10 days before drug administration or during the trial. However, over-the-counter drugs for external application (such as lubricant eye drops for contact lens, insect bite reliever) shall be allowed
Participation in another trial with an investigational drug within four months before drug administration or during the trial
Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese shochu, distilled alcoholic beverage)
Drug abuse
Blood donation (more than 100 mL within four weeks before drug administration or during the trial)
Excessive physical activities (within one week before administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms) or long QT syndroms
A history of additional risk factors for torsades de pointes (TdP) (e.g., heart failure, hypokalemia) or other cardiac arrhythmias
hyperthyroidism
Disagree with adequate contraception (the subject should use condoms and his partner should use oral contraception or intrauterine device [IUD]) during the study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1744 CL	BI 1744 CL	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of patients with abnormal findings in physical examination	Baseline, up to 13 days after last drug administration
Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)	Baseline, up to 13 days after last drug administration
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)	Baseline, up to 13 days after last drug administration
Number of patients with clinically significant changes in clinical laboratory tests	Baseline, up to 13 days after last drug administration
Change from baseline in potassium level	Baseline and Day 14
Number of patients with adverse events	7 weeks
Assessment of tolerability on a 4-point scale	Day 28

Secondary Outcome Measures

Name	Time	Method
t1/2 (terminal half-life of the analyte in plasma at different time points)	Up to day 18
tmax (time from dosing to maximum measured concentration of the analyte in plasma at different time points)	Up to day 18
AUC (area under the concentration-time curve of the analyte in plasma at different time points)	Up to day 18
%AUCtz-∞ (the percentage of the AUC 0-infinity that is obtained by extrapolation)	Up to day 18
Cmax (maximum measured concentration of the analyte in plasma at different time points)	Up to day 18
λz (terminal rate constant in plasma at different time points)	Up to day 18
MRTih (mean residence time of the analyte in the body after inhalation administration at different time points)	Up to day 18
Aeτ (amount of analyte that is eliminated in urine after administration over a uniform dosing interval τ at different time points)	Up to day 18
feτ (fraction of analyte eliminated in urine after administration over a uniform dosing interval τ at different time points)	Up to day 18
CLR (renal clearance of the analyte at different time points)	Up to day 18
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)	Up to day 18
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)	Up to day 18
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)	Up to day 18
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)	Up to day 18
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)	Up to day 18
Accumulation ratio (RA,AUC)	Up to day 18
Accumulation ratio (RA,Cmax)	Up to day 18

Multiple Rising Inhalative Doses of BI 1744 CL in Healthy Male Volunteers

Recruitment & Eligibility

Study & Design

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