Clinical trial NCT02273401: Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers
Official title: A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses (0.5 μg to 70 μg Administered With the Respimat®) of BI 11054 CL in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 96
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate safety, tolerability, and pharmacokinetics of BI 11054


Eligibility criteria: 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)

Primary outcomes:
measure: Number of subjects with clinically significant findings in physical examination
timeFrame: up to 18 days after drug administration
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: up to 18 days after drug administration
measure: Number of subjects with clinically significant findings in orthostasis tests
timeFrame: up to 24 hours after drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 18 days after drug administration
measure: Number of subjects with clinically significant findings in additional safety laboratory tests
timeFrame: up to 24 hours after drug administration
measure: Number of subjects with clinically significant changes in body temperature
timeFrame: up to 24 hours after drug administration
measure: Number of subjects with clinically significant findings in electrocardiogram (ECG)
timeFrame: up to 18 days after drug administration
measure: Number of subjects with adverse events
timeFrame: up to 18 days after drug administration
measure: Number of subjects with findings of oropharyngeal inspection
timeFrame: up to 24 hours after drug administration
measure: Number of subjects with findings of pulmonary auscultation
timeFrame: up to 24 hours after drug administration
measure: Airway resistance (Raw)
timeFrame: up to 24 hours after drug administration
measure: Global tolerability assessed by investigator on a 4-point scale
timeFrame: up to 18 days after drug administration
Secondary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 96 hours
measure: tmax (time from dosing to maximum measured concentration)
timeFrame: up to 96 hours
measure: 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)
timeFrame: up to 96 hours
measure: AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time t1 to time t2)
timeFrame: up to 96 hours
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 96 hours
measure: %AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation)
timeFrame: up to 96 hours
measure: λz (terminal rate constant in plasma)
timeFrame: up to 96 hours
measure: t1/2 (terminal half-life of the analyte in plasma)
timeFrame: up to 96 hours
measure: MRTih (mean residence time of the analyte in the body after inhalation)
timeFrame: up to 96 hours
measure: CL/F (apparent clearance of the analyte in plasma after extravascular administration)
timeFrame: up to 96 hours
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
timeFrame: up to 96 hours
measure: Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
timeFrame: up to 96 hours
measure: fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
timeFrame: up to 96 hours
measure: CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
timeFrame: up to 96 hours
Other outcomes:
Locations:
Study officials:
References: