- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02273401
Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers
October 23, 2014 updated by: Boehringer Ingelheim
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
To investigate safety, tolerability, and pharmacokinetics of BI 11054
Study Overview
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
|
EXPERIMENTAL: BI 11054 CL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with clinically significant findings in physical examination
Time Frame: up to 18 days after drug administration
|
up to 18 days after drug administration
|
|
Number of subjects with clinically significant findings in vital signs
Time Frame: up to 18 days after drug administration
|
blood pressure (BP), pulse rate (PR), respiratory rate (RR)
|
up to 18 days after drug administration
|
Number of subjects with clinically significant findings in orthostasis tests
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Number of subjects with clinically significant findings in laboratory tests
Time Frame: up to 18 days after drug administration
|
up to 18 days after drug administration
|
|
Number of subjects with clinically significant findings in additional safety laboratory tests
Time Frame: up to 24 hours after drug administration
|
cyclic adenosine monophosphate (cAMP) and potassium
|
up to 24 hours after drug administration
|
Number of subjects with clinically significant changes in body temperature
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Number of subjects with clinically significant findings in electrocardiogram (ECG)
Time Frame: up to 18 days after drug administration
|
up to 18 days after drug administration
|
|
Number of subjects with adverse events
Time Frame: up to 18 days after drug administration
|
up to 18 days after drug administration
|
|
Number of subjects with findings of oropharyngeal inspection
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Number of subjects with findings of pulmonary auscultation
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
|
Airway resistance (Raw)
Time Frame: up to 24 hours after drug administration
|
measured by body plethysmography
|
up to 24 hours after drug administration
|
Global tolerability assessed by investigator on a 4-point scale
Time Frame: up to 18 days after drug administration
|
up to 18 days after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame: up to 96 hours
|
up to 96 hours
|
tmax (time from dosing to maximum measured concentration)
Time Frame: up to 96 hours
|
up to 96 hours
|
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)
Time Frame: up to 96 hours
|
up to 96 hours
|
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time t1 to time t2)
Time Frame: up to 96 hours
|
up to 96 hours
|
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: up to 96 hours
|
up to 96 hours
|
%AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation)
Time Frame: up to 96 hours
|
up to 96 hours
|
λz (terminal rate constant in plasma)
Time Frame: up to 96 hours
|
up to 96 hours
|
t1/2 (terminal half-life of the analyte in plasma)
Time Frame: up to 96 hours
|
up to 96 hours
|
MRTih (mean residence time of the analyte in the body after inhalation)
Time Frame: up to 96 hours
|
up to 96 hours
|
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Time Frame: up to 96 hours
|
up to 96 hours
|
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time Frame: up to 96 hours
|
up to 96 hours
|
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time Frame: up to 96 hours
|
up to 96 hours
|
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time Frame: up to 96 hours
|
up to 96 hours
|
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time Frame: up to 96 hours
|
up to 96 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ACTUAL)
August 1, 2008
Study Registration Dates
First Submitted
October 23, 2014
First Submitted That Met QC Criteria
October 23, 2014
First Posted (ESTIMATE)
October 24, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
October 24, 2014
Last Update Submitted That Met QC Criteria
October 23, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 1250.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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