HealthyPhase 1NCT02273401
Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers
A Phase 1 study testing BI 11054 CL in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate safety, tolerability, and pharmacokinetics of BI 11054 Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 11054 CL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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)
About this study
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
To investigate safety, tolerability, and pharmacokinetics of BI 11054
- Conditions
- Healthy
- Being tested
- BI 11054 CL, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 11054 CLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 11054 CL | Experimental | Not described Receives: Drug: BI 11054 CL |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with clinically significant findings in physical examination
Measured: up to 18 days after drug administration
Number of subjects with clinically significant findings in vital signs
blood pressure (BP), pulse rate (PR), respiratory rate (RR)
Measured: up to 18 days after drug administration
Number of subjects with clinically significant findings in orthostasis tests
Measured: up to 24 hours after drug administration
Number of subjects with clinically significant findings in laboratory tests
Measured: up to 18 days after drug administration
Number of subjects with clinically significant findings in additional safety laboratory tests
cyclic adenosine monophosphate (cAMP) and potassium
Measured: up to 24 hours after drug administration
Number of subjects with clinically significant changes in body temperature
Measured: up to 24 hours after drug administration
Number of subjects with clinically significant findings in electrocardiogram (ECG)
Measured: up to 18 days after drug administration
Number of subjects with adverse events
Measured: up to 18 days after drug administration
Number of subjects with findings of oropharyngeal inspection
Measured: up to 24 hours after drug administration
Number of subjects with findings of pulmonary auscultation
Measured: up to 24 hours after drug administration
Airway resistance (Raw)
measured by body plethysmography
Measured: up to 24 hours after drug administration
Global tolerability assessed by investigator on a 4-point scale
Measured: up to 18 days after drug administration
Secondary outcomes (14)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 96 hours
tmax (time from dosing to maximum measured concentration)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: up to 96 hours
%AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation)
Measured: up to 96 hours
λz (terminal rate constant in plasma)
Measured: up to 96 hours
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 96 hours
MRTih (mean residence time of the analyte in the body after inhalation)
Measured: up to 96 hours
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Measured: up to 96 hours
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 96 hours
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: up to 96 hours
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: up to 96 hours
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJan 2008
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273401
- Sponsor's protocol ID
- 1250.1
- Status last verified
- Oct 2014
- First submitted
- 23 Oct 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02273401
- Acronym / sponsor ID
- 1250.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate safety, tolerability, and pharmacokinetics of BI 11054
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 11054 CL | Experimental | Drug: BI 11054 CL |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 11054 CL | Drug | BI 11054 CL |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with clinically significant findings in physical examination
Time frame: 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)
Number of subjects with clinically significant findings in orthostasis tests
Time frame: 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
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
Number of subjects with clinically significant changes in body temperature
Time frame: 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
Number of subjects with adverse events
Time frame: up to 18 days after drug administration
Number of subjects with findings of oropharyngeal inspection
Time frame: up to 24 hours after drug administration
Number of subjects with findings of pulmonary auscultation
Time frame: up to 24 hours after drug administration
Airway resistance (Raw)
Time frame: up to 24 hours after drug administration
measured by body plethysmography
Global tolerability assessed by investigator on a 4-point scale
Time frame: up to 18 days after drug administration
14 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 96 hours
tmax (time from dosing to maximum measured concentration)
Time frame: 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
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
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
%AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation)
Time frame: up to 96 hours
λz (terminal rate constant in plasma)
Time frame: up to 96 hours
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 96 hours
MRTih (mean residence time of the analyte in the body after inhalation)
Time frame: up to 96 hours
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Time frame: 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
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: 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
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 11054 CL in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with clinically significant findings in physical examination (time frame: up to 18 days after drug administration). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.