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

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ClinicalTrials.gov Identifier: NCT02254109
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 30, 2014
First Posted Date  ICMJE October 1, 2014
Last Update Posted Date October 1, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising of BEA 2180 BR in Japanese Healthy Male Volunteers
Official Title  ICMJE 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
Brief Summary Study to evaluate safety, tolerability, and pharmacokinetics of BEA 2180 BR in Japanese healthy volunteers
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BEA 2180 BR - rising dose
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: BEA 2180 BR - rising dose
    Intervention: Drug: BEA 2180 BR - rising dose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2014)
36
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02254109
Other Study ID Numbers  ICMJE 1205.18
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP