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CompletedNCT02254109Updated Oct 1, 2014

Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising of BEA 2180 BR in Japanese Healthy Male Volunteers

A Phase 1 interventional study of BEA 2180 BR - rising dose and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Male
01

Study summary

Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese healthy volunteers

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  1. 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

  2. Age ≥20 and ≤35 years
  3. Body mass index (BMI) ≥18.5 and ≤25 kg/m2
  4. Subjects must be able to inhale medication in a competent manner from the Respimat®
  5. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP)

Exclusion Criteria:

  1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts
  7. Chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity including allergy to drug or its excipients
  9. 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
  10. 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
  11. Participation in another trial with an investigational drug within four months before drug administration or during the trial
  12. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  13. Inability to refrain from smoking during the trial
  14. 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)
  15. Drug abuse
  16. Blood donation (≥100 mL within four weeks before drug administration or during the trial)
  17. Excessive physical activities (within one week before drug administration or during the trial)
  18. Any laboratory value outside the reference range that is of clinical relevance

  19. Inability to comply with dietary regimen of trial site

    Exclusion criteria specific for this study:

  20. Occupational (professional) exposure to antimuscarinic substances (e.g., physician, nurse, pharmacist etc.; volunteers working for medical institutions, research institutions or herb gardens)
  21. History of glaucoma, urination difficulty (due to prostatic hyperplasia etc.)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
36 participants (actual)

Study arms

  • Experimental
    BEA 2180 BR - rising dose

    Drug: BEA 2180 BR - rising dose

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBEA 2180 BR - rising dose
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Number of subjects with abnormal findings in physical examination

    Time frame: up to 28 days after last dose administration

  2. Number of subjects with clinically significant changes in vital signs

    Blood pressure and pulse rate

    Time frame: up to 28 days after last dose administration

  3. Number of subjects with clinically significant changes in 12-lead electrocardiogram (ECG)

    Time frame: up to 28 days after last dose administration

  4. Number of subjects with abnormal changes in laboratory parameters

    Time frame: up to 28 days after last dose administration

  5. Number of subjects with adverse events

    Time frame: up to 28 days after last dose administration

  6. Assessment of tolerability by the investigator on a 4-point scale

    Time frame: 28 days after last dose administration

Secondary outcomes

  1. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 648:00 hours

  2. tmax (time from dosing to maximum measured concentration of the analyte in plasma)

    Time frame: up to 648:00 hours

  3. 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

  4. 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

  5. Aeτ (amount of analyte that is eliminated in urine over a uniform dosing interval τ)

    Time frame: up to 648:00 hours

  6. feτ (fraction of analyte eliminated in urine over a uniform dosing interval τ)

    Time frame: up to 648:00 hours

  7. 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

  8. Cmin,ss (minimum concentration of the analyte in plasma at steady state)

    Time frame: up to 648:00 hours

  9. 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

  10. λz,ss (terminal rate constant in plasma at steady state)

    Time frame: up to 648:00 hours

  11. t1/2,ss (terminal half-life of the analyte in plasma at steady state)

    Time frame: up to 648:00 hours

  12. MRTih,ss (mean residence time of the analyte in the body at steady state after inhalation administration)

    Time frame: up to 648:00 hours

  13. 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

  14. 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

  15. Accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)

    Time frame: up to 648:00 hours

  16. Accumulation ratio of the analyte in plasma based on AUC (RA,AUC)

    Time frame: up to 648:00 hours

  17. Accumulation ratio of the analyte in plasma based on Ae (RA,Ae)

    Time frame: up to 648:00 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02254109
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 1, 2014
Start date
Apr 2008
Primary completion
Oct 2008
Last update
Oct 1, 2014
View the source record on ClinicalTrials.gov ↗

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