Via Respimat® Inhaled BI 1744 CL Compared to Moxifloxacin and Placebo in Healthy Male and Female Volunteers

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

All participants in the study will be healthy males or females, ranging from 21 to 50 years of age, with a body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters). In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria

Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of orthostatic hypotension, fainting spells or blackouts
Chronic or clinically relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Intake of drugs with a long half-life (> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (> 60 g/day for males and > 20 g/day for females)
Drug abuse
Blood donation (> 100 mL within four weeks prior to administration or during the trial)
Any laboratory value outside the reference range if indicative of underlying disease or poor health
Excessive physical activities within the last week before the trial or during the trial
Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes
Previous tendon disease related to quinolone treatment
Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias
Pulse rate at screening of > 80 bpm or < 45 bpm
Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR (Pulse rate) interval > 220 ms, QRS interval > 115 ms, QTcB > 450 ms, or QT (uncorrected) > 470 ms

For Female Subjects:

Pregnancy
Positive pregnancy test
No adequate contraception (adequate contraception e.g. sterilisation, intrauterine-pressure, oral contraceptives)
Inability to maintain this adequate contraception during the whole study period
Lactation period

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moxifloxacin (Avalox®)	Moxifloxacin (Avalox®)	-
BI 1744 CL	BI 1744 CL solution for inhalation	-
Placebo	Placebo matching BI 1744 CL	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the mean time-matched QTcI (QT interval, individually corrected according to the factor estimated from each subject)	Baseline (day -1) and 20 to 120 min. after drug administration

Secondary Outcome Measures

Name	Time	Method
Change of the QTcI at different point	Baseline (day -1) and 10 min. to 8 hours after drug administration
The mean of the QTcI values of all ECGs for Moxifloxacin and Placebo	1 to 4 hours after drug administration

Via Respimat® Inhaled BI 1744 CL Compared to Moxifloxacin and Placebo in Healthy Male and Female Volunteers

Recruitment & Eligibility

Study & Design

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