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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1744 CL solution for inhalation; Drug: Placebo matching BI 1744 CL; Drug: Moxifloxacin (Avalox®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02172144

1222.8

Details and patient eligibility

About

Study to investigate the effect of BI 1744 CL on the QT/QTc interval of the ECG (electrocardiogram) in comparison to placebo

Enrollment: 24 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

BI 1744 CL

Experimental group

Treatment:

Drug: BI 1744 CL solution for inhalation

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 1744 CL

Moxifloxacin (Avalox®)

Active Comparator group

Treatment:

Drug: Moxifloxacin (Avalox®)