HealthyPhase 1NCT02254720
Safety, Tolerability and Pharmacokinetics of BEA 2180 BR in Healthy Male Volunteers
A Phase 1 study testing BEA 2180 BR solution for infusion, BEA 2180 BR solution for inhalation and Respimat® in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of BEA 2180 BR; additional exploration of metabolism following inhalation 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?
- BEA 2180 BR solution for infusion, BEA 2180 BR solution for inhalation and Respimat®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Dec 2006
- 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
- BMI ≥18.5 and <29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
Who cannot join
- Any finding of the medical examination (including blood pressure (BP), pulse rate (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 23Show 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 enrolment in the study or during the study
- 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 (regularly more than 40 g alcohol per day for men)
- 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 anticholinergic drugs:
- hypersensitivity to tiotropium and/or related drugs of these classes
- history of narrow-angle glaucoma
- history of prostatic hyperplasia
- history of bladder-neck obstruction
About this study
Official title: A Randomised, Single-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses (2.5 μg, 7.5 μg, 25 μg, 50 μg, 100 μg, 200 μg, 350 μg, 500 μg Free Cation) BEA 2180 BR in Healthy Male Volunteers With an Additional Arm by Inhalation in One Dose Group (1600 μg)
Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of BEA 2180 BR; additional exploration of metabolism following inhalation
- Conditions
- Healthy
- Being tested
- BEA 2180 BR solution for infusion, Placebo, BEA 2180 BR solution for inhalation, Respimat®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEA 2180 BR solution for infusionDrug
PlaceboDrug
Intravenous infusion
BEA 2180 BR solution for inhalationDrug
Respimat®Device
| Study group | Role | What they receive |
|---|---|---|
| BEA 2180 BR IV | Experimental | Rising doses Receives: Drug: BEA 2180 BR solution for infusion |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BEA 2180 BR inhalation | Experimental | Not described Receives: Drug: BEA 2180 BR solution for inhalation; Device: Respimat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with abnormal findings in physical examination
Measured: Up to day 12 after drug administration
Number of participants with clinically significant changes in vital signs
Measured: Up to day 12 after drug administration
Number of participants with abnormal findings in 12 - lead ECG (electrocardiogram)
Measured: Up to day 12 after drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Measured: Up to day 12 after drug administration
Number of participants with adverse events
Measured: Up to day 12 after drug administration
Investigator assessed tolerability on a 4-point scale
Measured: Up to day 12 after drug administration
Secondary outcomes (14)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: Up to 72 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Measured: Up to 72 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Up to 72 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Measured: Up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: Up to 72 hours after drug administration
λz (terminal rate constant in plasma)
Measured: Up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: Up to 72 hours after drug administration
MRT(mean residence time of the analyte in the body)
Measured: Up to 72 hours after drug administration
CL (total clearance of the analyte in plasma)
Measured: Up to 72 hours after drug administration
Vz (apparent volume of distribution during the terminal phase λz)
Measured: Up to 72 hours after drug administration
Vss (apparent volume of distribution at steady state following intravascular administration)
Measured: Up to 72 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: Up to 72 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: Up to 72 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: Up to 72 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startSep 2006
- Primary completionDec 2006
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
- Single blind
- Enrolment
- 71 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
- NCT02254720
- Sponsor's protocol ID
- 1205.5
- Status last verified
- Sep 2014
- First submitted
- 1 Oct 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses (2.5 μg, 7.5 μg, 25 μg, 50 μg, 100 μg, 200 μg, 350 μg, 500 μg Free Cation) BEA 2180 BR in Healthy Male Volunteers With an Additional Arm by Inhalation in One Dose Group (1600 μg)
- ClinicalTrials.gov ID
- NCT02254720
- Acronym / sponsor ID
- 1205.5
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 2 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.
Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of BEA 2180 BR; additional exploration of metabolism following inhalation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BEA 2180 BR IV | Experimental | Drug: BEA 2180 BR solution for infusionRising doses |
| Placebo | Placebo comparator | Drug: Placebo |
| BEA 2180 BR inhalation | Experimental | Drug: BEA 2180 BR solution for inhalation, Device: Respimat® |
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
- BMI ≥18.5 and <29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
Key exclusion criteria (23 listed)
- Any finding of the medical examination (including blood pressure (BP), pulse rate (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 |
|---|---|---|
| BEA 2180 BR solution for infusion | Drug | BEA 2180 BR IV |
| PlaceboIntravenous infusion | Drug | Placebo |
| BEA 2180 BR solution for inhalation | Drug | BEA 2180 BR inhalation |
| Respimat® | Device | BEA 2180 BR inhalation |
Primary outcome
Number of participants with abnormal findings in physical examination
Time frame: Up to day 12 after drug administration
Number of participants with clinically significant changes in vital signs
Time frame: Up to day 12 after drug administration
Number of participants with abnormal findings in 12 - lead ECG (electrocardiogram)
Time frame: Up to day 12 after drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to day 12 after drug administration
Number of participants with adverse events
Time frame: Up to day 12 after drug administration
Investigator assessed tolerability on a 4-point scale
Time frame: Up to day 12 after drug administration
14 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 72 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: Up to 72 hours after drug administration
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 72 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: Up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: Up to 72 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 72 hours after drug administration
MRT(mean residence time of the analyte in the body)
Time frame: Up to 72 hours after drug administration
CL (total clearance of the analyte in plasma)
Time frame: Up to 72 hours after drug administration
Vz (apparent volume of distribution during the terminal phase λz)
Time frame: Up to 72 hours after drug administration
Vss (apparent volume of distribution at steady state following intravascular administration)
Time frame: Up to 72 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: Up to 72 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: Up to 72 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: Up to 72 hours after drug administration
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 2 Oct 2014.
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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 BEA 2180 BR solution for infusion, BEA 2180 BR solution for inhalation and Respimat® 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 23 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 2 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 participants with abnormal findings in physical examination (time frame: Up to day 12 after drug administration). The study lists 6 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 2 Oct 2014.