HealthyPhase 1NCT02263976
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BEA 2180 BR in Healthy Male Subjects
A Phase 1 study testing BEA 2180 BR, Respimat® A 4 and Methacholine Chloride in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide is able to protect of methacholine-induced bronchoconstriction compared to baseline (methacholine challenge at screening). Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BEA 2180 BR, Respimat® A 4 and Methacholine Chloride
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Jun 2004
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory test
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥ 30 and Age ≤ 55 years
- Body Mass Index (BMI) ≥ 18.5 and BMI < 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
- 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 allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator (or his deputy)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Show all 22Show fewer
- 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 administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
- Bronchial hyperreactivity as demonstrated by a 45% change of SGaw at or below a cumulative methacholine concentration of 10 mg/mL = 1%
- Asthma or bronchial hyperreactivity
- Allergic rhinitis (hay fever)
- Glaucoma
- Urinary tract obstruction
- Epilepsy
- History of cardiovascular disease
- History of peptic ulcer disease
- History of thyroid disease
About this study
Official title: Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Rising Inhaled BEA 2180 BR Doses (2.5 μg to 1600 μg Cation Administered With the Respimat®) in Healthy Male Subjects, Alone and Followed by Methacholine Challenge. A Randomised, Double-blind Within Dose Group, Placebo-controlled Study, With a 36 μg Tiotropium Bromide Single Dose Sub-study (Open, Two-fold Crossover).
Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide is able to protect of methacholine-induced bronchoconstriction compared to baseline (methacholine challenge at screening).
- Conditions
- Healthy
- Being tested
- BEA 2180 BR, Placebo, Respimat® A 4, Methacholine Chloride, Spiriva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEA 2180 BRDrug
PlaceboDrug
Respimat® A 4Device
Methacholine ChlorideDrug
methacholine challenge test
SpirivaDrug
Also called tiotropium bromide
| Study group | Role | What they receive |
|---|---|---|
| BEA 2180 BR | Experimental | single rising doses Receives: Drug: BEA 2180 BR; Device: Respimat® A 4; Drug: Methacholine Chloride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Device: Respimat® A 4; Drug: Methacholine Chloride |
| Sub-Study | Experimental | Not described Receives: Drug: Methacholine Chloride; Drug: Spiriva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with clinically significant changes in vital signs
blood pressure, pulse rate, respiratory rate, oral body temperature
Measured: up to 14 days after last drug administration
Number of subjects with clinically significant changes in laboratory parameters
Measured: up to 14 days after last drug administration
Changes from baseline in airway resistance (Raw)
assessed by body plethysmography
Measured: up to 120 hours after drug administration
Changes from baseline in specific airway conductance (sGaw)
assessed by body plethysmography
Measured: up to 120 hours after drug administration
Number of subjects with clinically significant findings in 12-lead ECG (electrocardiogram)
Measured: up to 14 days after last drug administration
Number of subjects with adverse events
Measured: up to 14 days after last drug administration
Assessment of tolerability by investigator on a 5-point scale
Measured: within 14 days after last drug administration
Secondary outcomes (14)
Changes from baseline in salivary secretion
Measured: up to 24 hours after drug administration
Changes from baseline in pupil diameter of each eye
pupillometry
Measured: up to 4 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to 240 hours after drug administration
Measured concentration of the analyte in plasma (C) for several time points
Measured: up to 24 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Measured: up to 240 hours after drug administration
Amount of parent drug that is eliminated in urine (Ae)
Measured: up to 312 hours after drug administration
Fraction of administered drug excreted unchanged in urine (fe)
Measured: up to 312 hours after drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
Measured: up to 240 hours after drug administration
Renal clearance of the analyte (CLR)
Measured: up to 312 hours after drug administration
Terminal rate constant of the analyte in plasma (λZ)
Measured: up to 240 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to 240 hours after drug administration
Mean residence time of the analyte in the body after inhaled administration (MRTinh)
Measured: up to 240 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Measured: up to 240 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (VZ/F)
Measured: up to 240 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 posted15 Oct 2014 (estimated)
- Study startAug 2003
- Primary completionJun 2004
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
- 101 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
- NCT02263976
- Sponsor's protocol ID
- 1205.1
- Other IDs
- 1205.9001
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Rising Inhaled BEA 2180 BR Doses (2.5 μg to 1600 μg Cation Administered With the Respimat®) in Healthy Male Subjects, Alone and Followed by Methacholine Challenge. A Randomised, Double-blind Within Dose Group, Placebo-controlled Study, With a 36 μg Tiotropium Bromide Single Dose Sub-study (Open, Two-fold Crossover).
- ClinicalTrials.gov ID
- NCT02263976
- Acronym / sponsor ID
- 1205.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Jun 2004 (actual)
- First posted
- 15 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.
Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide is able to protect of methacholine-induced bronchoconstriction compared to baseline (methacholine challenge at screening).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BEA 2180 BR | Experimental | Drug: BEA 2180 BR, Device: Respimat® A 4, Drug: Methacholine Chloridesingle rising doses |
| Placebo | Placebo comparator | Drug: Placebo, Device: Respimat® A 4, Drug: Methacholine Chloride |
| Sub-Study | Experimental | Drug: Methacholine Chloride, Drug: Spiriva |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male volunteers based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory test
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Age ≥ 30 and Age ≤ 55 years
- Body Mass Index (BMI) ≥ 18.5 and BMI < 30 kg/m2
Key exclusion criteria (22 listed)
- 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 allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator (or his deputy)
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 | Drug | BEA 2180 BR |
| Placebo | Drug | Placebo |
| Respimat® A 4 | Device | BEA 2180 BR, Placebo |
| Methacholine Chloridemethacholine challenge test | Drug | BEA 2180 BR, Placebo, Sub-Study |
| SpirivaAlso: tiotropium bromide | Drug | Sub-Study |
Primary outcome
Number of subjects with clinically significant changes in vital signs
Time frame: up to 14 days after last drug administration
blood pressure, pulse rate, respiratory rate, oral body temperature
Number of subjects with clinically significant changes in laboratory parameters
Time frame: up to 14 days after last drug administration
Changes from baseline in airway resistance (Raw)
Time frame: up to 120 hours after drug administration
assessed by body plethysmography
Changes from baseline in specific airway conductance (sGaw)
Time frame: up to 120 hours after drug administration
assessed by body plethysmography
Number of subjects with clinically significant findings in 12-lead ECG (electrocardiogram)
Time frame: up to 14 days after last drug administration
Number of subjects with adverse events
Time frame: up to 14 days after last drug administration
Assessment of tolerability by investigator on a 5-point scale
Time frame: within 14 days after last drug administration
14 secondary outcomes
Changes from baseline in salivary secretion
Time frame: up to 24 hours after drug administration
Changes from baseline in pupil diameter of each eye
Time frame: up to 4 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 240 hours after drug administration
Measured concentration of the analyte in plasma (C) for several time points
Time frame: up to 24 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 240 hours after drug administration
Amount of parent drug that is eliminated in urine (Ae)
Time frame: up to 312 hours after drug administration
Fraction of administered drug excreted unchanged in urine (fe)
Time frame: up to 312 hours after drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: up to 240 hours after drug administration
Renal clearance of the analyte (CLR)
Time frame: up to 312 hours after drug administration
Terminal rate constant of the analyte in plasma (λZ)
Time frame: up to 240 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 240 hours after drug administration
Mean residence time of the analyte in the body after inhaled administration (MRTinh)
Time frame: up to 240 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: up to 240 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (VZ/F)
Time frame: up to 240 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 15 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, Respimat® A 4 and Methacholine Chloride 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 6 inclusion and 22 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 15 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 changes in vital signs (time frame: up to 14 days after last drug administration). The study lists 7 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 15 Oct 2014.