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

NCT02172144 | Completed Phase 1

• 1 other identifier: 1222.8
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

BI 1744 CL

EXPERIMENTAL

Drug: BI 1744 CL solution for inhalation

Placebo

PLACEBO COMPARATOR

Drug: Placebo matching BI 1744 CL

Moxifloxacin (Avalox®)

ACTIVE COMPARATOR

Drug: Moxifloxacin (Avalox®)

Interventions

BI 1744 CL solution for inhalation DRUG

BI 1744 CL

Placebo matching BI 1744 CL DRUG

Placebo

Moxifloxacin (Avalox®) DRUG

Moxifloxacin (Avalox®)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Solutions; Inhalation; Moxifloxacin

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2007
• Primary Completion: October 1, 2007
• Last Updated: June 24, 2014

Record last verified: 2014-06