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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BEA 2180 BR in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02254122
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR

Condition or disease Intervention/treatment Phase
Healthy Drug: BEA 2180 BR Drug: Placebo Device: Respimat® Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (20 µg, 50 µg, 100 µg, 200 µg and 400 µg) of BEA 2180 BR for 21 Days in Healthy Male Volunteers (Double-blind, Randomised, Placebo Controlled [at Each Dose Level] Study)
Study Start Date : May 2004
Actual Primary Completion Date : February 2005

Arm Intervention/treatment
Experimental: BEA 2180 BR Drug: BEA 2180 BR
Device: Respimat®
Placebo Comparator: Placebo Drug: Placebo
Device: Respimat®



Primary Outcome Measures :
  1. Number of subjects with abnormal findings in physical examination [ Time Frame: up to day 42 ]
  2. Number of subjects with clinically significant changes in vital signs [ Time Frame: up to day 42 ]
  3. Number of subjects with clinically significant changes in 12-lead electrocardiogram [ Time Frame: up to day 42 ]
  4. Number of subjects with clinically significant changes in laboratory parameters [ Time Frame: up to day 42 ]
  5. Changes in effective airway resistance (Reff) [ Time Frame: up to day 25 ]
    Body plethysmography

  6. Changes in specific effective airway conductance (SGeff) [ Time Frame: up to day 25 ]
    Body plethysmography

  7. Changes in salivary secretion [ Time Frame: up to day 21 ]
  8. Number of subjects with adverse events [ Time Frame: up to day 42 ]
  9. Assessment of tolerability by the Investigator on a 4-point rating scale [ Time Frame: day 42 ]

Secondary Outcome Measures :
  1. Maximum concentration of the analyte in plasma for several time points [ Time Frame: up to day 35 ]
  2. Time from dosing to maximum concentration in plasma for several time points [ Time Frame: up to day 35 ]
  3. Area under the concentration-time curve of the analyte in plasma for several time points [ Time Frame: up to day 35 ]
  4. Amount of analyte that is eliminated in urine for several time points [ Time Frame: up to day 34 ]
  5. Fraction of analyte excreted in urine for several time points [ Time Frame: up to day 34 ]
  6. Renal clearance of the analyte in plasma for several time points [ Time Frame: up to day 34 ]
  7. Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval [ Time Frame: up to day 35 ]
  8. Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose [ Time Frame: up to day 35 ]
  9. Terminal rate constant in plasma at steady state (λz,ss) [ Time Frame: up to day 35 ]
  10. Terminal half-life of the analyte in plasma at steady state (t1/2,ss) [ Time Frame: up to day 35 ]
  11. Mean residence time of the analyte in the body after 21 administrations at steady state (MRTih,ss) [ Time Frame: up to day 35 ]
  12. apparent clearance of the analyte in the plasma after extravascular administration at steady state (CL/F,ss) [ Time Frame: up to day 35 ]
  13. apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss) [ Time Frame: up to day 35 ]
  14. Accumulation ratio (RA) of the analyte in plasma after multiple dose administration over a uniform dosing interval τ [ Time Frame: up to day 35 ]
  15. Peak trough fluctuation (PTF) [ Time Frame: up to day 35 ]


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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males according to the following criteria (examined at the Screening Visit):

    Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

    1.1 No finding deviating from normal and of clinical relevance

    1.2 No evidence of a clinically relevant concomitant disease

  2. Age ≥30 and ≤55 years
  3. BMI ≥18.5 and BMI < 30 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  3. History of relevant orthostatic hypotension, fainting spells or blackouts
  4. Chronic or relevant acute infections
  5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the Investigator
  6. 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
  7. 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
  8. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  9. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  10. Inability to refrain from smoking during the trial
  11. Alcohol abuse (more than 60 g/day)
  12. Drug abuse
  13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  14. Excessive physical activities (within one week prior to administration or during the trial)
  15. Any laboratory value outside the reference range if indicative of underlying disease or poor health

Exclusion criteria specific for this study:

  • Asthma or chronic obstructive pulmonary disease
  • Glaucoma
  • Urinary tract obstruction
  • Occupational (professional) exposure to antimuscarinic substances
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254122    
Other Study ID Numbers: 1205.2
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014