HealthyPhase 1NCT02254109
Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising of BEA 2180 BR in Japanese Healthy Male Volunteers
A Phase 1 study testing BEA 2180 BR - rising dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese healthy volunteers Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BEA 2180 BR - rising dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Oct 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese men:
- According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
- Age ≥20 and ≤35 years
- Body mass index (BMI) ≥18.5 and ≤25 kg/m2
- Subjects must be able to inhale medication in a competent manner from the Respimat®
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 21Show fewer
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity including allergy to drug or its excipients
- Intake of drugs with a long half-life (>24 hours) within one month or less than 10 half-lives of the respective drug before drug administration or during the trial
- Use of prescription or non-prescription drugs within 10 days before drug Administration or during the trial. However, over-the-counter (OTC) drugs for external application (such as lubricant eye drops for contact lens, insect bite reliever) shall be allowed
- Participation in another trial with an investigational drug within four months before drug administration or during the trial
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking during the trial
- Alcohol abuse (≥60 g/day: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese shochu, distilled alcoholic beverage)
- Drug abuse
- Blood donation (≥100 mL within four weeks before drug administration or during the trial)
- Excessive physical activities (within one week before drug administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- Occupational (professional) exposure to antimuscarinic substances (e.g., physician, nurse, pharmacist etc.; volunteers working for medical institutions, research institutions or herb gardens)
- History of glaucoma, urination difficulty (due to prostatic hyperplasia etc.)
About this study
Official title: A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses (50 μg, 100 μg and 200 μg q.d. for 14 Days) of BEA 2180 BR in Japanese Healthy Male Volunteers
Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese healthy volunteers
- Conditions
- Healthy
- Being tested
- BEA 2180 BR - rising dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEA 2180 BR - rising doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BEA 2180 BR - rising dose | Experimental | Not described Receives: Drug: BEA 2180 BR - rising dose |
| 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 abnormal findings in physical examination
Measured: up to 28 days after last dose administration
Number of subjects with clinically significant changes in vital signs
Blood pressure and pulse rate
Measured: up to 28 days after last dose administration
Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG)
Measured: up to 28 days after last dose administration
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 28 days after last dose administration
Number of subjects with adverse events
Measured: up to 28 days after last dose administration
Assessment of tolerability by the investigator on a 4-point scale
Measured: 28 days after last dose administration
Secondary outcomes (17)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 648:00 hours
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: up to 648:00 hours
AUCτ (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ)
Measured: up to 648:00 hours
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)
Measured: up to 648:00 hours
Aeτ (amount of analyte that is eliminated in urine over a uniform dosing interval τ)
Measured: up to 648:00 hours
feτ (fraction of analyte eliminated in urine over a uniform dosing interval τ)
Measured: up to 648:00 hours
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: up to 648:00 hours
Cmin,ss (minimum concentration of the analyte in plasma at steady state)
Measured: up to 648:00 hours
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Measured: up to 648:00 hours
λz,ss (terminal rate constant in plasma at steady state)
Measured: up to 648:00 hours
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Measured: up to 648:00 hours
MRTih,ss (mean residence time of the analyte in the body at steady state after inhalation administration)
Measured: up to 648:00 hours
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
Measured: up to 648:00 hours
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Measured: up to 648:00 hours
Accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)
Measured: up to 648:00 hours
Accumulation ratio of the analyte in plasma based on AUC (RA,AUC)
Measured: up to 648:00 hours
Accumulation ratio of the analyte in plasma based on Ae (RA,Ae)
Measured: up to 648:00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startApr 2008
- Primary completionOct 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
- 36 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
- NCT02254109
- Sponsor's protocol ID
- 1205.18
- Status last verified
- Sep 2014
- First submitted
- 30 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 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 Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses (50 μg, 100 μg and 200 μg q.d. for 14 Days) of BEA 2180 BR in Japanese Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02254109
- Acronym / sponsor ID
- 1205.18
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- First posted
- 1 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.
Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEA 2180 BR - rising dose | Experimental | Drug: BEA 2180 BR - rising dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Japanese men:
- According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
- Age ≥20 and ≤35 years
- Body mass index (BMI) ≥18.5 and ≤25 kg/m2
- Subjects must be able to inhale medication in a competent manner from the Respimat®
Key exclusion criteria (21 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 - rising dose | Drug | BEA 2180 BR - rising dose |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with abnormal findings in physical examination
Time frame: up to 28 days after last dose administration
Number of subjects with clinically significant changes in vital signs
Time frame: up to 28 days after last dose administration
Blood pressure and pulse rate
Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 28 days after last dose administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 28 days after last dose administration
Number of subjects with adverse events
Time frame: up to 28 days after last dose administration
Assessment of tolerability by the investigator on a 4-point scale
Time frame: 28 days after last dose administration
17 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 648:00 hours
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: up to 648:00 hours
AUCτ (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ)
Time frame: up to 648:00 hours
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)
Time frame: up to 648:00 hours
Aeτ (amount of analyte that is eliminated in urine over a uniform dosing interval τ)
Time frame: up to 648:00 hours
feτ (fraction of analyte eliminated in urine over a uniform dosing interval τ)
Time frame: up to 648:00 hours
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 648:00 hours
Cmin,ss (minimum concentration of the analyte in plasma at steady state)
Time frame: up to 648:00 hours
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: up to 648:00 hours
λz,ss (terminal rate constant in plasma at steady state)
Time frame: up to 648:00 hours
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to 648:00 hours
MRTih,ss (mean residence time of the analyte in the body at steady state after inhalation administration)
Time frame: up to 648:00 hours
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
Time frame: up to 648:00 hours
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: up to 648:00 hours
Accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)
Time frame: up to 648:00 hours
Accumulation ratio of the analyte in plasma based on AUC (RA,AUC)
Time frame: up to 648:00 hours
Accumulation ratio of the analyte in plasma based on Ae (RA,Ae)
Time frame: up to 648:00 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 1 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 - rising dose 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 21 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 1 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 abnormal findings in physical examination (time frame: up to 28 days after last dose 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 1 Oct 2014.